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1.
Cochrane Database Syst Rev ; 3: CD012457, 2022 03 29.
Artigo em Inglês | MEDLINE | ID: mdl-35349162

RESUMO

BACKGROUND: Surgical options for treating stress urinary incontinence (SUI) are usually explored after conservative interventions have failed. Surgeries fall into two categories: traditional techniques (open surgery) and minimally invasive procedures, such as laparoscopic procedures, midurethral sling and injections with urethral bulking agents. Postsurgery infections, such as infections of the surgical site or urinary tract, are common complications. To minimise the risk of postoperative bacterial infections, prophylactic antibiotics may be given before or during surgery.  OBJECTIVES: To assess the effects of prophylactic antibiotics for preventing infection following continence surgery in women with stress urinary incontinence.  SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov and WHO ICTRP; and handsearched journals and conference proceedings to 18 March 2021. We also searched the reference lists of relevant articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs assessing prophylactic antibiotics in women undergoing continence surgery to treat SUI. DATA COLLECTION AND ANALYSIS: Two review authors selected potentially eligible trials, extracted data and assessed risk of bias. We expressed results as risk ratios (RR) for dichotomous outcomes and as mean differences (MD) for continuous outcomes, both with 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach. MAIN RESULTS: We identified one quasi-RCT and two RCTs, involving a total of 390 women. One study performed retropubic urethropexy surgery requiring a transverse suprapubic incision, while the other two studies performed midurethral sling surgery. It should be noted that none of the included studies clearly specified the timing of outcome assessment. We are very uncertain whether prophylactic antibiotics (cefazolin) have an effect on surgical site infections (RR 0.56, 95% CI 0.03 to 12.35; 2 studies, 85 women; very low-certainty evidence) or urinary tract infections or bacteriuria (RR 0.84, 95% CI 0.05 to 13.24; 2 studies, 85 women; very low-certainty evidence). The effect of prophylactic antibiotics (cefazolin) on febrile morbidity is also uncertain (RR 0.08, 95% CI 0.00 to 1.29; 2 studies, 85 women; very low-certainty evidence). We are very uncertain whether prophylactic antibiotics (cefazolin) have any effect on mesh exposure (RR 0.32, 95% CI 0.01 to 7.61; 1 study, 59 women; very low-certainty evidence). None of the three included studies described the assessment of adverse events from antibiotic use, sepsis or bacteraemia in their reports. AUTHORS' CONCLUSIONS: Only limited data are available from the three included studies and, overall, the certainty of evidence was very low. Moreover, the three included studies evaluated different surgical procedures and dosages of antibiotic administration. Thus, there is insufficient evidence to support or refute the use of prophylactic antibiotics to prevent infection following anti-incontinence surgery. In addition, there were no data regarding adverse effects of prophylactic antibiotics. More RCTs are required.


Assuntos
Slings Suburetrais , Incontinência Urinária por Estresse , Incontinência Urinária , Antibacterianos/uso terapêutico , Feminino , Humanos , Masculino , Slings Suburetrais/efeitos adversos , Uretra/cirurgia , Incontinência Urinária por Estresse/cirurgia
2.
Cochrane Database Syst Rev ; 9: CD005528, 2018 09 28.
Artigo em Inglês | MEDLINE | ID: mdl-30264405

RESUMO

BACKGROUND: Caesarean section rates are increasing globally. The factors contributing to this increase are complex, and identifying interventions to address them is challenging. Non-clinical interventions are applied independently of a clinical encounter between a health provider and a patient. Such interventions may target women, health professionals or organisations. They address the determinants of caesarean births and could have a role in reducing unnecessary caesarean sections. This review was first published in 2011. This review update will inform a new WHO guideline, and the scope of the update was informed by WHO's Guideline Development Group for this guideline. OBJECTIVES: To evaluate the effectiveness and safety of non-clinical interventions intended to reduce unnecessary caesarean section. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers in March 2018. We also searched websites of relevant organisations and reference lists of related reviews. SELECTION CRITERIA: Randomised trials, non-randomised trials, controlled before-after studies, interrupted time series studies and repeated measures studies were eligible for inclusion. The primary outcome measures were: caesarean section, spontaneous vaginal birth and instrumental birth. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures recommended by Cochrane. We narratively described results of individual studies (drawing summarised evidence from single studies assessing distinct interventions). MAIN RESULTS: We included 29 studies in this review (19 randomised trials, 1 controlled before-after study and 9 interrupted time series studies). Most of the studies (20 studies) were conducted in high-income countries and none took place in low-income countries. The studies enrolled a mixed population of pregnant women, including nulliparous women, multiparous women, women with a fear of childbirth, women with high levels of anxiety and women having undergone a previous caesarean section.Overall, we found low-, moderate- or high-certainty evidence that the following interventions have a beneficial effect on at least one primary outcome measure and no moderate- or high-certainty evidence of adverse effects.Interventions targeted at women or familiesChildbirth training workshops for mothers alone may reduce caesarean section (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.33 to 0.89) and may increase spontaneous vaginal birth (RR 2.25, 95% CI 1.16 to 4.36). Childbirth training workshops for couples may reduce caesarean section (RR 0.59, 95% CI 0.37 to 0.94) and may increase spontaneous vaginal birth (RR 2.13, 95% CI 1.09 to 4.16). We judged this one study with 60 participants to have low-certainty evidence for the outcomes above.Nurse-led applied relaxation training programmes (RR 0.22, 95% CI 0.11 to 0.43; 104 participants, low-certainty evidence) and psychosocial couple-based prevention programmes (RR 0.53, 95% CI 0.32 to 0.90; 147 participants, low-certainty evidence) may reduce caesarean section. Psychoeducation may increase spontaneous vaginal birth (RR 1.33, 95% CI 1.11 to 1.61; 371 participants, low-certainty evidence). The control group received routine maternity care in all studies.There were insufficient data on the effect of the four interventions on maternal and neonatal mortality or morbidity.Interventions targeted at healthcare professionalsImplementation of clinical practice guidelines combined with mandatory second opinion for caesarean section indication slightly reduces the risk of overall caesarean section (mean difference in rate change -1.9%, 95% CI -3.8 to -0.1; 149,223 participants). Implementation of clinical practice guidelines combined with audit and feedback also slightly reduces the risk of caesarean section (risk difference (RD) -1.8%, 95% CI -3.8 to -0.2; 105,351 participants). Physician education by local opinion leader (obstetrician-gynaecologist) reduced the risk of elective caesarean section to 53.7% from 66.8% (opinion leader education: 53.7%, 95% CI 46.5 to 61.0%; control: 66.8%, 95% CI 61.7 to 72.0%; 2496 participants). Healthcare professionals in the control groups received routine care in the studies. There was little or no difference in maternal and neonatal mortality or morbidity between study groups. We judged the certainty of evidence to be high.Interventions targeted at healthcare organisations or facilitiesCollaborative midwifery-labourist care (in which the obstetrician provides in-house labour and delivery coverage, 24 hours a day, without competing clinical duties), versus a private practice model of care, may reduce the primary caesarean section rate. In one interrupted time series study, the caesarean section rate decreased by 7% in the year after the intervention, and by 1.7% per year thereafter (1722 participants); the vaginal birth rate after caesarean section increased from 13.3% before to 22.4% after the intervention (684 participants). Maternal and neonatal mortality were not reported. We judged the certainty of evidence to be low.We studied the following interventions, and they either made little or no difference to caesarean section rates or had uncertain effects.Moderate-certainty evidence suggests little or no difference in caesarean section rates between usual care and: antenatal education programmes for physiologic childbirth; antenatal education on natural childbirth preparation with training in breathing and relaxation techniques; computer-based decision aids; individualised prenatal education and support programmes (versus written information in pamphlet).Low-certainty evidence suggests little or no difference in caesarean section rates between usual care and: psychoeducation; pelvic floor muscle training exercises with telephone follow-up (versus pelvic floor muscle training without telephone follow-up); intensive group therapy (cognitive behavioural therapy and childbirth psychotherapy); education of public health nurses on childbirth classes; role play (versus standard education using lectures); interactive decision aids (versus educational brochures); labourist model of obstetric care (versus traditional model of obstetric care).We are very uncertain as to the effect of other interventions identified on caesarean section rates as the certainty of the evidence is very low. AUTHORS' CONCLUSIONS: We evaluated a wide range of non-clinical interventions to reduce unnecessary caesarean section, mostly in high-income settings. Few interventions with moderate- or high-certainty evidence, mainly targeting healthcare professionals (implementation of guidelines combined with mandatory second opinion, implementation of guidelines combined with audit and feedback, physician education by local opinion leader) have been shown to safely reduce caesarean section rates. There are uncertainties in existing evidence related to very-low or low-certainty evidence, applicability of interventions and lack of studies, particularly around interventions targeted at women or families and healthcare organisations or facilities.


Assuntos
Cesárea/estatística & dados numéricos , Educação Pré-Natal , Terapia de Relaxamento , Procedimentos Desnecessários/estatística & dados numéricos , Ansiedade/terapia , Estudos Controlados Antes e Depois , Feminino , Fidelidade a Diretrizes , Humanos , Análise de Séries Temporais Interrompida , Parto/psicologia , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Encaminhamento e Consulta/estatística & dados numéricos , Nascimento Vaginal Após Cesárea/estatística & dados numéricos
3.
Cochrane Database Syst Rev ; 5: CD011283, 2018 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-29761891

RESUMO

BACKGROUND: Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) may complicate a patient's postoperative recovery in several ways. Monitoring of processed electroencephalogram (EEG) or evoked potential (EP) indices may prevent or minimize POD and POCD, probably through optimization of anaesthetic doses. OBJECTIVES: To assess whether the use of processed EEG or auditory evoked potential (AEP) indices (bispectral index (BIS), narcotrend index, cerebral state index, state entropy and response entropy, patient state index, index of consciousness, A-line autoregressive index, and auditory evoked potentials (AEP index)) as guides to anaesthetic delivery can reduce the risk of POD and POCD in non-cardiac surgical or non-neurosurgical adult patients undergoing general anaesthesia compared with standard practice where only clinical signs are used. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and clinical trial registry databases up to 28 March 2017. We updated this search in February 2018, but these results have not been incorporated in the review. SELECTION CRITERIA: We included randomized or quasi-randomized controlled trials comparing any method of processed EEG or evoked potential techniques (entropy, BIS, AEP etc.) against a control group where clinical signs were used to guide doses of anaesthetics in adults aged 18 years or over undergoing general anaesthesia for non-cardiac or non-neurosurgical elective operations. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were: occurrence of POD; and occurrence of POCD. Secondary outcomes included: all-cause mortality; any postoperative complications; and postoperative length of stay. We used GRADE to assess the quality of evidence for each outcome. MAIN RESULTS: We included six randomized controlled trials (RCTs) with 2929 participants comparing processed EEG or EP indices-guided anaesthesia with clinical signs-guided anaesthesia. There are five ongoing studies and one study awaiting classification.Anaesthesia administration guided by the indices from a processed EEG (bispectral index) probably reduces the risk of POD within seven days after surgery with risk ratio (RR) of 0.71 (95% CI 0.59 to 0.85; number needed to treat for an additional beneficial outcome (NNTB) of 17, 95% CI 11 to 34; 2197 participants; 3 RCTs; moderate quality of evidence). Three trials also showed the lower rate of POCD at 12 weeks after surgery (RR 0.71, 95% CI 0.53 to 0.96; NNTB 38, 95% CI 21 to 289; 2051 participants; moderate-quality evidence), but it is uncertain whether processed EEG indices reduce POCD at one week (RR 0.84, 95% CI 0.69 to 1.02; 3 trials; 1989 participants; moderate-quality evidence), and at 52 weeks (RR 0.30, 95% CI 0.05 to 1.80; 1 trial; 59 participants; very low quality of evidence). There may be little or no effect on all-cause mortality (RR 1.01, 95% CI 0.62 to 1.64; 1 trial; 1155 participants; low-quality evidence). One trial suggested a lower risk of any postoperative complications with processed EEG (RR 0.51, 95% CI 0.37 to 0.71; 902 participants, moderate-quality evidence). There may be little or no effect on reduced postoperative length of stay (mean difference -0.2 days, 95% CI -2.02 to 1.62; 1155 participants; low-quality evidence). AUTHORS' CONCLUSIONS: There is moderate-quality evidence that optimized anaesthesia guided by processed EEG indices could reduce the risk of postoperative delirium in patients aged 60 years or over undergoing non-cardiac surgical and non-neurosurgical procedures. We found moderate-quality evidence that postoperative cognitive dysfunction at three months could be reduced in these patients. The effect on POCD at one week and over one year after surgery is uncertain. There are no data available for patients under 60 years. Further blinded randomized controlled trials are needed to elucidate strategies for the amelioration of postoperative delirium and postoperative cognitive dysfunction, and their consequences such as dementia (including Alzheimer's disease (AD)) in both non-elderly (below 60 years) and elderly (60 years or over) adult patients. The one study awaiting classification and five ongoing studies may alter the conclusions of the review once assessed.


Assuntos
Anestésicos/administração & dosagem , Disfunção Cognitiva/prevenção & controle , Delírio/prevenção & controle , Eletroencefalografia , Potenciais Evocados Auditivos , Complicações Pós-Operatórias/prevenção & controle , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Idoso , Anestesia Geral/métodos , Causas de Morte , Estado de Consciência , Entropia , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Cochrane Database Syst Rev ; 12: CD010157, 2016 12 07.
Artigo em Inglês | MEDLINE | ID: mdl-27925149

RESUMO

BACKGROUND: Respiratory hazards are common in the workplace. Depending on the hazard and exposure, the health consequences may include: mild to life-threatening illnesses from infectious agents, acute effects ranging from respiratory irritation to chronic lung conditions, or even cancer from exposure to chemicals or toxins. Use of respiratory protective equipment (RPE) is an important preventive measure in many occupational settings. RPE only offers protection when worn properly, when removed safely and when it is either replaced or maintained regularly. The effectiveness of behavioural interventions either directed at employers or organisations or directed at individual workers to promote RPE use in workers remains an important unanswered question. OBJECTIVES: To assess the effects of any behavioural intervention either directed at organisations or at individual workers on observed or self-reported RPE use in workers when compared to no intervention or an alternative intervention. SEARCH METHODS: We searched the Cochrane Work Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 07), MEDLINE (1980 to 12 August 2016), EMBASE (1980 to 20 August 2016) and CINAHL (1980 to 12 August 2016). SELECTION CRITERIA: We included randomised controlled trials (RCTs), controlled before and after (CBA) studies and interrupted time-series (ITS) comparing behavioural interventions versus no intervention or any other behavioural intervention to promote RPE use in workers. DATA COLLECTION AND ANALYSIS: Four authors independently selected relevant studies, assessed risk of bias and extracted data. We contacted investigators to clarify information. We pooled outcome data from included studies where the studies were sufficiently similar. MAIN RESULTS: We included 14 studies that evaluated the effect of training and education on RPE use, which involved 2052 participants. The included studies had been conducted with farm, healthcare, production line, office and coke oven workers as well as nursing students and people with mixed occupations. All included studies reported the effects of interventions as use of RPE, as correct use of RPE or as indirect measures of RPE use. We did not find any studies where the intervention was delivered and assessed at the whole organization level or in which the main focus was on positive or negative incentives. We rated the quality of the evidence for all comparisons as low to very low. Training versus no trainingOne CBA study in healthcare workers compared training with and without a fit test to no intervention. The study found that the rate of properly fitting respirators was not considerably different in the workers who had received training with a fit test (RR 1.17, 95% Confidence Interval (CI) 0.97 to 1.10) or training without a fit test (RR 1.16, 95% CI 0.95 to 1.42) compared to those who had no training. Two RCTs that evaluated training did not contribute to the analyses because of lack of data. Conventional training plus additions versus conventional training aloneOne cluster-randomised trial compared conventional training plus RPE demonstration versus training alone and reported no significant difference in appropriate use of RPE between the two groups (RR 1.41, 95% CI 0.96 to 2.07).One RCT compared interactive training with passive training, with an information screen, and an information book. The mean RPE performance score for the active group was not different from that of the passive group (MD 2.10, 95% CI -0.76 to 4.96). However, the active group scored significantly higher than the book group (MD 4.20, 95% CI 0.89 to 7.51) and the screen group (MD 7.00, 95% CI 4.06 to 9.94).One RCT compared computer-simulation training with conventional personal protective equipment (PPE) training but reported only results for donning and doffing full-body PPE. Education versus no educationOne RCT found that a multifaceted educational intervention increased the use of RPE (risk ratio (RR) 1.69, 95% CI 1.10 to 2.58) at three years' follow-up when compared to no intervention. However, there was no difference between intervention and control at one year's, two years' or four years' follow-up. Two RCTs did not report enough data to be included in the analysis.Four CBA studies evaluated the effectiveness of education interventions and found no effect on the frequency or correctness of RPE use, except in one study for the use of an N95 mask (RR 4.56, 95% CI 1.84 to 11.33, 1 CBA) in workers. Motivational interviewing versus traditional lecturesOne CBA study found that participants given motivational group interviewing-based safety education scored higher on a checklist measuring PPE use (MD 2.95, 95% CI 1.93 to 3.97) than control workers given traditional educational sessions. AUTHORS' CONCLUSIONS: There is very low quality evidence that behavioural interventions, namely education and training, do not have a considerable effect on the frequency or correctness of RPE use in workers. There were no studies on incentives or organisation level interventions. The included studies had methodological limitations and we therefore need further large RCTs with clearer methodology in terms of randomised sequence generation, allocation concealment and assessor blinding, in order to evaluate the effectiveness of behavioural interventions for improving the use of RPE at both organisational and individual levels. In addition, further studies should consider some of the barriers to the successful use of RPE, such as experience of health risk, types of RPE and the employer's attitude to RPE use.


Assuntos
Promoção da Saúde/métodos , Dispositivos de Proteção Respiratória/estatística & dados numéricos , Local de Trabalho , Estudos Controlados Antes e Depois , Fazendeiros , Pessoal de Saúde , Humanos , Análise de Séries Temporais Interrompida , Entrevista Motivacional , Ocupações , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Cochrane Database Syst Rev ; 12: CD006425, 2016 12 06.
Artigo em Inglês | MEDLINE | ID: mdl-27922724

RESUMO

BACKGROUND: Breast milk is well recognised as the best food source for infants. The impact of antenatal breastfeeding (BF) education on the duration of BF has not been evaluated. OBJECTIVES: To assess the effectiveness of antenatal breastfeeding (BF) education for increasing BF initiation and duration. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register on 1 March 2016, CENTRAL (The Cochrane Library, 2016, Issue 3), MEDLINE (1966 to 1 March 2016) and Scopus (January 1985 to 1 March 2016). We contacted experts and searched reference lists of retrieved articles. SELECTION CRITERIA: All identified published, unpublished and ongoing randomised controlled trials (RCTs) assessing the effect of formal antenatal BF education or comparing two different methods of formal antenatal BF education, on the duration of BF. We included RCTs that only included antenatal interventions and excluded those that combined antenatal and intrapartum or postpartum BF education components. Cluster-randomised trials were included in this review. Quasi-randomised trials were not eligible for inclusion. DATA COLLECTION AND ANALYSIS: We assessed all potential studies identified as a result of the search strategy. Two review authors extracted data from each included study using the agreed form and assessed risk of bias. We resolved discrepancies through discussion. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: This review update includes 24 studies (10,056 women). Twenty studies (9789 women) contribute data to analyses. Most studies took place in high-income countries such as the USA, UK, Canada and Australia. In the first five comparisons, we display the included trials according to type of intervention without pooling data. For the 'Summary of findings' we pooled data for a summary effect.Five included studies were cluster-randomised trials: all of these adjusted data and reported adjustments as odds ratios (OR). We have analysed the data using the generic inverse variance method and presented results as odds ratios, because we were unable to derive a cluster-adjusted risk ratio from the published cluster-trial. We acknowledge that the use of odds ratio prevents the pooling of these cluster trials in our main analyses. One method of BF education with standard (routine) careThere were no group differences for duration of any BF in days or weeks. There was no evidence that interventions improved the proportion of women with any BF or exclusive BF at three or six months. Single trials of different interventions were unable to show that education improved initiation of BF, apart from one small trial at high risk of attrition bias. Many trial results marginally favoured the intervention but had wide confidence intervals crossing the line of no effect. BF complications such as mastitis and other BF problems were similar in treatment arms in single trials reporting these outcomes. Multiple methods of BF education versus standard careFor all trials included in this comparison we have presented the cluster-adjusted odds ratios as reported in trial publications. One three-arm study found the intervention of BF booklet plus video plus Lactation Consultant versus standard care improved the proportion of women exclusively BF at three months (OR 2.60, 95% CI 1.25 to 5.40; women = 159) and marginally at six months (OR 2.40, 95% CI 1.00 to 5.76; women = 175). For the same trial, an intervention arm without a lactation consultant but with the BF booklet and video did not have the same effect on proportion of women exclusively BF at three months (OR 1.80, 95% CI 0.80 to 4.05; women = 159) or six months (OR 0.90, 95% CI 0.30 to 2.70; women = 184). One study compared monthly BF sessions and weekly cell phone message versus standard care and reported improvements in the proportion of women exclusively BF at both three and six months (three months OR 1.80, 95% CI 1.10 to 2.95; women = 390; six months OR 2.40, 95% CI 1.40 to 4.11; women = 390). One study found monthly BF sessions and weekly cell phone messages improved initiation of BF over standard care (OR 2.61, 95% CI 1.61 to 4.24; women = 380). BF education session versus standard care, pooled analyses for 'Summary of findings' (SoF)This comparison does not include cluster-randomised trials reporting adjusted odds ratios. We did not downgrade any evidence for trials' lack of blinding; no trial had adequate blinding of staff and participants. The SoF table presents risk ratios for all outcomes analysed. For proportion of women exclusively BF there is no evidence that antenatal BF education improved BF at three months (RR 1.06, 95% CI 0.90 to 1.25; women = 822; studies = 3; moderate quality evidence) or at six months (RR 1.07, 95% CI 0.87 to 1.30; women = 2161; studies = 4; moderate quality evidence). For proportion of women with any BF there were no group differences in BF at three (average RR 0.98, 95% CI 0.82 to 1.18; women = 654; studies = 2; I² = 60%; low-quality evidence) or six months (average RR 1.05, 95% CI 0.90 to 1.23; women = 1636; studies = 4; I² = 61%; high-quality evidence). There was no evidence that antenatal BF education could improve initiation of BF (average RR 1.01, 95% CI 0.94 to 1.09; women = 3505; studies = 8; I² = 69%; high-quality evidence). Where we downgraded evidence this was due to small sample size or wide confidence intervals crossing the line of no effect, or both.There was insufficient data for subgroup analysis of mother's occupation or education. AUTHORS' CONCLUSIONS: There was no conclusive evidence supporting any antenatal BF education for improving initiation of BF, proportion of women giving any BF or exclusively BF at three or six months or the duration of BF. There is an urgent need to conduct a high-quality, randomised controlled study to evaluate the effectiveness and adverse effects of antenatal BF education, especially in low- and middle-income countries. Evidence in this review is primarily relevant to high-income settings.


Assuntos
Aleitamento Materno , Mães/educação , Cuidado Pré-Natal/métodos , Aleitamento Materno/estatística & dados numéricos , Aconselhamento/métodos , Feminino , Humanos , Grupo Associado , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo
6.
Cochrane Database Syst Rev ; 10: CD006623, 2016 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-27731501

RESUMO

BACKGROUND: Functional endoscopic sinus surgery (FESS) is a minimally invasive technique that is used to treat chronic sinusitis. Small bleeding areas can reduce operative visibility and result in destruction of surrounding structures. Deliberate hypotension (lowering the mean arterial blood pressure to between 50 and 65 mm Hg in normotensive patients) using a range of pharmacological agents during general anaesthesia reduces blood loss in many operations. This review was originally published in 2013 and updated in February 2016. OBJECTIVES: We aimed to compare the use of propofol versus other techniques for achieving deliberate intraoperative hypotension during FESS procedures with regard to blood loss and operative conditions. SEARCH METHODS: We searched the following databases in the updated review: the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (1950 to February 2016), Embase (1980 to February 2016), LILACS (1982 to February 2016), and ISI Web of Science (1946 to February 2016). We also searched the reference lists of relevant articles and conference proceedings and contacted the authors of included trials. SELECTION CRITERIA: We sought all randomized controlled trials comparing propofol with other techniques for deliberate hypotension during FESS with regard to blood loss and operative conditions in both adults and children. Our primary outcome was total blood loss (TBL). Other outcomes included surgical field quality, operation time, mortality within 24 hours, complications, and failure to reach target blood pressure. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently extracted details of trial methodology and outcome data from the reports of all trials considered eligible for inclusion. We made all analyses on an intention-to-treat basis where possible. When I2 was less than 40% and the P value from the Chi2 test was higher than 0.10, we pooled data using the fixed-effect model. Otherwise, we pooled data using the random-effects model. MAIN RESULTS: We found no new studies. This updated review therefore includes four studies with 278 participants. Most analyses were based on data from few participants and low-quality evidence, so our results should be interpreted with caution. Deliberate hypotension with propofol did not decrease TBL (millilitres) when compared with inhalation anaesthetics in either children (1 study; 70 participants; very low-quality evidence), or adults (1 study; 88 participants; moderate-quality evidence). Propofol improved the quality of the surgical field by less than one category on a scale from 0 (no bleeding) to 5 (severe bleeding) (mean difference -0.64, 95% CI -0.91 to -0.37; 4 studies; 277 participants; low-quality evidence), but no difference in operation time was reported (3 studies; 214 participants; low-quality evidence). Failure to lower blood pressure to target was less common in the propofol group (risk ratio of failure with propofol 0.24, 95% CI 0.09 to 0.66; 1 study; 88 participants; moderate-quality evidence). AUTHORS' CONCLUSIONS: Using propofol to achieve deliberate hypotension probably improves the surgical field, but the effect is small. Deliberate hypotension with propofol did not decrease TBL and the operation time. However, due to the very low quality of the evidence, this conclusion is not definitive. Randomized controlled trials with good-quality methodology and large sample size are required to investigate the effectiveness of deliberate hypotension with propofol for FESS.


Assuntos
Anestésicos Intravenosos , Perda Sanguínea Cirúrgica/prevenção & controle , Endoscopia/efeitos adversos , Hipotensão Controlada/métodos , Seios Paranasais/cirurgia , Propofol , Adulto , Criança , Endoscopia/métodos , Humanos , Duração da Cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto
8.
Cochrane Database Syst Rev ; (1): CD006014, 2016 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-26747297

RESUMO

BACKGROUND: Interval debulking surgery (IDS), following induction or neoadjuvant chemotherapy, may have a role in treating advanced epithelial ovarian cancer (stage III to IV) where primary debulking surgery is not an option. OBJECTIVES: To assess the effectiveness and complications of IDS for women with advanced stage epithelial ovarian cancer. SEARCH METHODS: We searched the Cochrane Gynaecological Cancer Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) 2012, Issue 6, MEDLINE and EMBASE for the original review in to June 2012. We updated the searches in June 2009, 2012 and 2015 for the review updates. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing survival of women with advanced epithelial ovarian cancer, who had IDS performed between cycles of chemotherapy after primary surgery with survival of women who had conventional treatment (primary debulking surgery and adjuvant chemotherapy). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Searches for additional information from study authors were attempted. We performed meta-analysis of overall and progression-free survival (PFS), using random-effects models. MAIN RESULTS: Three RCTs randomising 853 women, of whom 781 were evaluated, met the inclusion criteria. Meta-analysis of three trials for overall survival (OS) found no statistically significant difference between IDS and chemotherapy alone (hazard ratio (HR) = 0.80, 95% confidence interval (CI) 0.61 to 1.06, I² = 58%). Subgroup analysis for OS in two trials, where the primary surgery was not performed by gynaecologic oncologists or was less extensive, showed a benefit of IDS (HR = 0.68, 95% CI 0.53 to 0.87, I² = 0%). Meta-analysis of two trials for PFS found no statistically significant difference between IDS and chemotherapy alone (HR = 0.88, 95% CI 0.57 to 1.33, I² = 83%). Rates of toxic reactions to chemotherapy were similar in both arms (risk ratio = 1.19, 95% CI 0.53 to 2.66, I² = 0%), but little information was available for other adverse events or quality or life (QoL). AUTHORS' CONCLUSIONS: We found no conclusive evidence to determine whether IDS between cycles of chemotherapy would improve or decrease the survival rates of women with advanced ovarian cancer, compared with conventional treatment of primary surgery followed by adjuvant chemotherapy. IDS appeared to yield benefit only in women whose primary surgery was not performed by gynaecologic oncologists or was less extensive. Data on QoL and adverse events were inconclusive.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/cirurgia , Quimioterapia Adjuvante/mortalidade , Terapia Combinada/métodos , Feminino , Humanos , Quimioterapia de Indução/mortalidade , Terapia Neoadjuvante/métodos , Terapia Neoadjuvante/mortalidade , Neoplasias Ovarianas/mortalidade , Neoplasias Ovarianas/patologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Taxa de Sobrevida , Carga Tumoral/efeitos dos fármacos
9.
Cochrane Database Syst Rev ; (1): CD011732, 2016 Jan 23.
Artigo em Inglês | MEDLINE | ID: mdl-26801659

RESUMO

BACKGROUND: Ovarian cancer is the third most common gynaecological cancer worldwide, with an age-standardised incidence rate of 6.1 per 10,000 women. Standard therapy for advanced epithelial ovarian cancer (EOC) includes a combination of cytoreductive surgery and platinum-based chemotherapy. Cytoreductive surgery aims to remove as much of the visible tumour as possible. As extensive intraperitoneal metastases are typical of advanced EOC, cytoreductive surgery is usually an extensive procedure with the risk of excessive bleeding. Tranexamic acid given perioperatively is effective in reducing blood loss and allogeneic blood transfusion requirements in a variety of surgical settings. Therefore, tranexamic acid seems to be a promising agent for minimising blood loss and the need for blood transfusion among women with advanced EOC undergoing cytoreductive surgery. OBJECTIVES: To assess the effects of tranexamic acid for reducing blood loss associated with cytoreductive surgery in women with advanced EOC (stage III to IV). SEARCH METHODS: We searched the Cochrane Gynaecological, Neuro-oncology and Orphan Cancers Trial Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2015), MEDLINE, EMBASE and conference proceedings to May 2015. We also checked registers of clinical trials, citation lists of included studies, key textbooks and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing tranexamic acid given during surgery versus placebo or no treatment, in adult women diagnosed with advanced EOC. DATA COLLECTION AND ANALYSIS: Two review authors (CK, AS) independently selected potentially relevant trials, extracted data, assessed risk of bias, compared results and resolved disagreements by discussion. MAIN RESULTS: We found only one study that met our inclusion criteria. This was a randomised double blind, placebo-controlled multicentre study conducted to evaluate the effectiveness of a single dose of intravenous tranexamic acid (15 mg/kg body weight) versus placebo, given immediately before surgery for reducing blood loss and the need for red blood cell transfusion. The mean total estimated blood loss was 668.34 mL and 916.93 mL for participants assigned to tranexamic acid and placebo groups, respectively. The mean difference (MD) of total estimated blood loss between the groups did not show a clinically important effect (MD - 248.59 mL; 95% confidence interval (CI) - 550.9 to 53.79; one study, 100 participants; moderate quality evidence). The mean number of transfused units of blood components was not different between the two groups (low quality evidence). There were no noted differences in the incidence of reoperation, readmission or thromboembolic events (very low quality evidence). We considered the methodology of the included study to be at low risk of selection, detection, and reporting biases. However, we were concerned about an imbalance of some baseline characteristics between the groups, and as there was no protocol for blood transfusion, the rate of blood transfusion may vary depending on the practice of each participating hospital. AUTHORS' CONCLUSIONS: Currently, there is insufficient evidence to recommend the routine use of tranexamic acid for reducing blood loss in women undergoing cytoreductive surgery for advanced EOC, as only limited data are available from a single, low quality RCT at low overall risk of bias.


Assuntos
Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos de Citorredução/métodos , Transfusão de Eritrócitos/estatística & dados numéricos , Neoplasias Ovarianas/cirurgia , Ácido Tranexâmico/uso terapêutico , Adulto , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Feminino , Humanos , Incidência , Neoplasias Ovarianas/patologia , Readmissão do Paciente/estatística & dados numéricos , Plasma , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação/estatística & dados numéricos , Tromboembolia/epidemiologia
10.
Cochrane Database Syst Rev ; (9): CD010198, 2015 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-26352008

RESUMO

BACKGROUND: Virtual reality simulation uses computer-generated imagery to present a simulated training environment for learners. This review seeks to examine whether there is evidence to support the introduction of virtual reality surgical simulation into ear, nose and throat surgical training programmes. OBJECTIVES: 1. To assess whether surgeons undertaking virtual reality simulation-based training achieve surgical ('patient') outcomes that are at least as good as, or better than, those achieved through conventional training methods.2. To assess whether there is evidence from either the operating theatre, or from controlled (simulation centre-based) environments, that virtual reality-based surgical training leads to surgical skills that are comparable to, or better than, those achieved through conventional training. SEARCH METHODS: The Cochrane Ear, Nose and Throat Disorders Group (CENTDG) Trials Search Co-ordinator searched the CENTDG Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 6); PubMed; EMBASE; ERIC; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 27 July 2015. SELECTION CRITERIA: We included all randomised controlled trials and controlled trials comparing virtual reality training and any other method of training in ear, nose or throat surgery. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by The Cochrane Collaboration. We evaluated both technical and non-technical aspects of skill competency. MAIN RESULTS: We included nine studies involving 210 participants. Out of these, four studies (involving 61 residents) assessed technical skills in the operating theatre (primary outcomes). Five studies (comprising 149 residents and medical students) assessed technical skills in controlled environments (secondary outcomes). The majority of the trials were at high risk of bias. We assessed the GRADE quality of evidence for most outcomes across studies as 'low'. Operating theatre environment (primary outcomes) In the operating theatre, there were no studies that examined two of three primary outcomes: real world patient outcomes and acquisition of non-technical skills. The third primary outcome (technical skills in the operating theatre) was evaluated in two studies comparing virtual reality endoscopic sinus surgery training with conventional training. In one study, psychomotor skill (which relates to operative technique or the physical co-ordination associated with instrument handling) was assessed on a 10-point scale. A second study evaluated the procedural outcome of time-on-task. The virtual reality group performance was significantly better, with a better psychomotor score (mean difference (MD) 1.66, 95% CI 0.52 to 2.81; 10-point scale) and a shorter time taken to complete the operation (MD -5.50 minutes, 95% CI -9.97 to -1.03). Controlled training environments (secondary outcomes) In a controlled environment five studies evaluated the technical skills of surgical trainees (one study) and medical students (three studies). One study was excluded from the analysis. Surgical trainees: One study (80 participants) evaluated the technical performance of surgical trainees during temporal bone surgery, where the outcome was the quality of the final dissection. There was no difference in the end-product scores between virtual reality and cadaveric temporal bone training. Medical students: Two other studies (40 participants) evaluated technical skills achieved by medical students in the temporal bone laboratory. Learners' knowledge of the flow of the operative procedure (procedural score) was better after virtual reality than conventional training (SMD 1.11, 95% CI 0.44 to 1.79). There was also a significant difference in end-product score between the virtual reality and conventional training groups (SMD 2.60, 95% CI 1.71 to 3.49). One study (17 participants) revealed that medical students acquired anatomical knowledge (on a scale of 0 to 10) better during virtual reality than during conventional training (MD 4.3, 95% CI 2.05 to 6.55). No studies in a controlled training environment assessed non-technical skills. AUTHORS' CONCLUSIONS: There is limited evidence to support the inclusion of virtual reality surgical simulation into surgical training programmes, on the basis that it can allow trainees to develop technical skills that are at least as good as those achieved through conventional training. Further investigations are required to determine whether virtual reality training is associated with better real world outcomes for patients and the development of non-technical skills. Virtual reality simulation may be considered as an additional learning tool for medical students.


Assuntos
Simulação por Computador , Instrução por Computador/métodos , Otolaringologia/educação , Procedimentos Cirúrgicos Otorrinolaringológicos/educação , Competência Clínica , Humanos , Internato e Residência , Salas Cirúrgicas , Desempenho Psicomotor , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudantes de Medicina
11.
Cochrane Database Syst Rev ; (12): CD010401, 2014 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-25470408

RESUMO

BACKGROUND: Current standard treatment for patients with cervical cancer who have locally advanced stage disease (International Federation of Gynecology and Obstetrics (FIGO) stage IIB to IVA) is concurrent chemoradiation therapy (CCRT). However, less than two-thirds of patients in this group survive for longer than five years post treatment. Adjuvant chemotherapy (ACT) can be given in an attempt to improve survival by eradicating residual disease in the pelvis and treating occult disease outside the pelvic radiation field. However, inconsistency in trial design, inclusion criteria for participants, interventions and survival benefit has been noted among trials of ACT after CCRT for locally advanced cervical cancer (LACC). OBJECTIVES: To evaluate the effect of adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) on survival of women with locally advanced cervical cancer compared with CCRT alone. SEARCH METHODS: We searched the Cochrane Gynaecological Review Group Trial Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and conference proceedings to March 2014. We handsearched citation lists of relevant studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing CCRT alone versus CCRT plus ACT were included. Patients were diagnosed with cervical cancer FIGO stage IIB to IVA with a histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma. DATA COLLECTION AND ANALYSIS: Two review authors (ST, KK) selected relevant trials, extracted data, assessed risk of bias independently, compared results and resolved disagreements by discussion. MAIN RESULTS: We identified two RCTs involving 978 women with cervical cancer stage IIB to IVA. As the trials were significantly different clinically, we did not perform meta-analyses. One industry-funded trial involving 515 women compared CCRT (cisplatin) versus CCRT (cisplatin and gemcitabine) plus ACT (two additional cycles). This trial reported significant improvement in progression-free survival (PFS) and overall survival (OS) in women who were given CCRT plus ACT compared with those treated with CCRT alone: Three-year PFS was 74.4% versus 65.0% (hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.49 to 0.95, P value 0.027), and three-year OS was 80% versus 69% (HR 0.68, 95% CI 0.49 to 0.95, P value 0.022). However, as the CCRT chemotherapy differed between the two arms, we considered the findings to be at high risk of bias.The second trial was a four-arm study from which we extracted data on 463 women in two study arms receiving CCRT (intravenous mitomycin C and oral 5-fluorouracil (5-FU)) or CCRT plus ACT (oral 5-FU for three cycles). The HR for OS in women who received ACT after CCRT compared with the HR for OS in those who were given CCRT alone was 1.309 (95% CI 0.795 to 2.157), and the HR for disease-free survival (DFS) was 1.125 (95% CI 0.799 to 1.586).Haematological adverse events were more common in the ACT arms of both trials. Quality of life (QoL) was not reported in either trial. AUTHORS' CONCLUSIONS: With limited data from only two trials, we found insufficient evidence to support the use of ACT after CCRT. Future large trials are required to demonstrate efficacy, toxicities and QoL.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimiorradioterapia/métodos , Neoplasias do Colo do Útero/terapia , Quimiorradioterapia/mortalidade , Quimioterapia Adjuvante/efeitos adversos , Quimioterapia Adjuvante/métodos , Quimioterapia Adjuvante/mortalidade , Cisplatino/administração & dosagem , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Feminino , Fluoruracila/administração & dosagem , Humanos , Mitomicina/administração & dosagem , Estadiamento de Neoplasias , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias do Colo do Útero/mortalidade , Neoplasias do Colo do Útero/patologia , Gencitabina
12.
Cochrane Database Syst Rev ; (11): CD007879, 2014 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-25385500

RESUMO

BACKGROUND: Infant hepatitis B infection increases the risk of chronic infection, cirrhosis or liver cancer (hepatocellular carcinoma) in the adult. Perinatal transmission is a common route of infection. OBJECTIVES: To assess the effectiveness and adverse effects of hepatitis B vaccine administered to pregnant women for preventing hepatitis B virus infection in infants. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2014). SELECTION CRITERIA: Randomized controlled trials (RCTs) assessing hepatitis B vaccination compared with placebo or no treatment during pregnancy for preventing infant infection. Quasi-RCTs and cross-over studies were not eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion. If any studies had been included, we planned to assess the risk of bias, extract data and check the data for accuracy of all included studies. MAIN RESULTS: We did not identify any studies for inclusion. AUTHORS' CONCLUSIONS: We found no RCTs that assessed the effects of hepatitis B vaccine during pregnancy for preventing infant infection. Consequently, this review cannot provide guidance for clinical practice in this area. However, it does identify the need for well-designed randomized clinical trials to assess the effect of hepatitis B vaccine during pregnancy on the incidence of infant infection and to determine any adverse effects.


Assuntos
Vacinas contra Hepatite B/administração & dosagem , Hepatite B/transmissão , Transmissão Vertical de Doenças Infecciosas/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , Vacinação , Adulto , Feminino , Humanos , Lactente , Gravidez
13.
Cochrane Database Syst Rev ; (11): CD007044, 2014 Nov 24.
Artigo em Inglês | MEDLINE | ID: mdl-25418417

RESUMO

BACKGROUND: Stones in the urinary tract are a common medical problem in the general population. At present, the great expansion in minimally invasive techniques has led to the decrease in open surgery. Extracorporeal shock wave lithotripsy (ESWL) has been introduced as an alternative approach which disintegrates stones in the kidney and upper urinary tract through the use of shock waves. Nevertheless, as there are limitations with the success rate in ESWL, other minimally invasive modalities for kidney stones such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS) are also widely applied. This is an update of a review first published in 2009. OBJECTIVES: This review aimed to assess the effectiveness and complications of ESWL for kidney stones compared with PCNL or RIRS. SEARCH METHODS: We searched the Cochrane Renal Group's Specialised Register to 3 March 2014 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. SELECTION CRITERIA: Randomised controlled trials (RCTs) assessing the use of ESWL compared to PCNL or RIRS for kidney stone management. DATA COLLECTION AND ANALYSIS: Two authors independently assessed all the studies for inclusion. Statistical analyses were performed using the random effects model and the results expressed as risk ratio (RR) for dichotomous outcomes or mean difference (MD) for continuous data with 95% confidence intervals (CI). MAIN RESULTS: Five studies (338 patients) were included, four studies compared ESWL to PCNL and one compared ESWL with RIRS. Random sequence generation was reported in three studies and unclear in two. Allocation concealment was not reported in any of the included studies. Blinding of participants and investigators could not be undertaken due to the nature of the interventions; blinding of outcome assessors was not reported. Reporting bias was judged to be low risk in all studies. One study was funded by industry and in one study the number of participants in each group was unbalanced.The success of treatment at three months was significantly greater in the PCNL compared to the ESWL group (3 studies, 201 participants: RR 0.46, 95% CI 0.35 to 0.62). Re-treatment (1 study, 122 participants: RR 1.81, 95% CI 0.66 to 4.99) and using auxiliary procedures (2 studies, 184 participants: RR 9.06, 95% CI 1.20 to 68.64) was significantly increased with ESWL group compared to PCNL. The efficiency quotient (EQ; used to assess the effectiveness of procedures) higher for PCNL than ESWL; however EQ decreased when stone size increased. Duration of treatment (MD -36.00 min, 95% CI -54.10 to -17.90) and hospital stay (1 study, 49 participants: MD -3.30 days, 95% CI -5.45 to -1.15) were significantly shorter in the ESWL group. Overall more complications were reported with PCNL, however we were unable to meta-analyse the included studies due to the differing outcomes reported and the timing of the outcome measurements.One study compared ESWL versus RIRS for lower pole kidney stones. The success of treatment was not significantly different at the end of the third month (58 participants: RR 0.91, 95% CI 0.64 to 1.30). Mean procedural time and mean hospital stay was reported to be longer in the RIRS group. AUTHORS' CONCLUSIONS: Results from five small studies, with low methodological quality, indicated ESWL is less effective for kidney stones than PCNL but not significantly different from RIRS. Hospital stay and duration of treatment was less with ESWL. Larger RCTs with high methodological quality are required to investigate the effectiveness and complications of ESWL for kidney stones compared to PCNL if there is any technological progress in the non-invasive elimination of the residual fragments. Moreover, further research is required for the outcomes of ESWL and RIRS in lower and non-lower pole studies including PCNL versus RIRS.


Assuntos
Cálculos Renais/terapia , Litotripsia , Nefrostomia Percutânea , Humanos , Cálculos Renais/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação , Ureteroscopia
14.
Knee Surg Sports Traumatol Arthrosc ; 22(1): 142-53, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23238925

RESUMO

PURPOSE: To compare bioabsorbable screw (BS) against metal screw (MS) primarily on adverse effects and secondarily on clinical outcomes after single-bundle primary anterior cruciate ligament reconstruction. METHODS: Electronic searches were performed using search strategies meeting the mentioned purposes. Retrieved articles were selected for randomised controlled trials (RCTs) reporting at least 1-year follow-up. Potential studies were selected under inclusion and exclusion criteria. Risk of biases and data extraction was completed by two review authors. Discrepancies were resolved through discussion. Mean difference and risk ratio with 95 % confidence interval (CI) were used for continuous and binary outcomes, respectively. Heterogeneity was assessed using I (2). Pooled treatment effects with 95 % CI were estimated using the fixed- or random-effect model where appropriate. RESULTS: Eleven RCTs with 878 randomly allocated patients were included, and 711 patients (81 %) with eligible follow-up time up to 8 years were analysed. Comparing with the MS group, BS group using medial hamstring graft showed evidence of larger tunnel widening on the femoral side measured from radiographs or magnetic resonance imaging, though data could not be pooled because diverse measurement methods had been used. Significantly higher rates of effusion and screw breakage, and fewer cases of complete tunnel healing were reported in the BS group. Nevertheless, functional and clinical results were not deteriorated by the presence of these adverse effects for both short- and longer-term follow-ups. CONCLUSION: This is the first systematic review focusing on adverse effects of the BS, such as larger tunnel widening and higher rates of other complications. With these effects, routine use of the BS should be balanced with the advantages claimed. Cost-effectiveness is another issue, and well-designed RCTs are needed to better validate the implication.


Assuntos
Reconstrução do Ligamento Cruzado Anterior/instrumentação , Parafusos Ósseos , Implantes Absorvíveis , Reconstrução do Ligamento Cruzado Anterior/métodos , Artroscopia , Materiais Biocompatíveis , Análise Custo-Benefício , Desenho de Equipamento , Fêmur/cirurgia , Humanos , Imageamento por Ressonância Magnética , Metais , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Cochrane Database Syst Rev ; (9): CD005056, 2013 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-24085642

RESUMO

BACKGROUND: Cervical dilatation and uterine intervention can be performed under sedation, local or general anaesthesia for obstetrics and gynaecological conditions. Many gynaecologists use paracervical local anaesthesia but its effectiveness is unclear. This review was originally published in 2009 and was updated in 2013. OBJECTIVES: The objectives of this review were to determine the effectiveness and safety of paracervical local anaesthesia for cervical dilatation and uterine intervention, versus no treatment, placebo, other methods of regional anaesthesia, sedation and systemic analgesia, and general anaesthesia. SEARCH METHODS: We reran our search to August 2013. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE (1966 to August 2013), EMBASE (1980 to August 2013), and reference lists of articles. The original search was performed in January 2006. SELECTION CRITERIA: We included randomized or controlled clinical studies involving women who underwent cervical dilatation and uterine intervention for obstetrics and gynaecological conditions. We included studies which compared paracervical anaesthesia with no treatment, placebo, other methods of regional anaesthesia, systemic sedation and analgesia, or general anaesthesia. DATA COLLECTION AND ANALYSIS: Two authors independently evaluated the studies, extracted data, and checked and entered data into Review Manager. MAIN RESULTS: This updated review includes nine new studies, in total 26 studies with 28 comparisons and involving 2790 participants. No study of local paracervical versus general anaesthesia met our criteria. Ten studies compared local anaesthetic versus placebo. Paracervical local anaesthetic (PLA) reduced pain on cervical dilatation with a standardized mean difference (SMD) of 0.37 (95% CI 0.17 to 0.58) and a relative risk (RR) of severe pain of 0.16 (95% CI 0.06 to 0.74). PLA also reduced abdominal pain during, but not after, uterine intervention (SMD 0.74, 95% CI 0.28 to 1.19); there was no evidence of any effect on postoperative back or shoulder pain. Comparisons against no treatment did not demonstrate any effect of PLA. Five studies compared paracervical block with uterosacral block, intracervical block, or intrauterine topical anaesthesia. Two of these studies showed no significant difference in pain during the procedure. Compared to intrauterine instillation, PLA slightly reduced severe pain (from 8.3 to 7.6 on a 10-point scale), which may be negligible. Six studies compared PLA with sedation. There were no statistically significant differences in pain during or after the procedure, postoperative analgesia requirement, adverse effects, patient satisfaction, and the operator's perception of analgesia. We performed risk of bias assessment using six domains and found that more than half of the included studies had low risk of bias. AUTHORS' CONCLUSIONS: We found that no technique provided reliable pain control in the 26 included studies. Some studies reported that women experienced severe pain (mean scores of 7 to 9 out of 10) during uterine intervention, irrespective of the analgesic technique used. We concluded that the available evidence fails to show whether paracervical block is inferior, equivalent, or superior to alternative analgesic techniques in terms of efficacy and safety for women undergoing cervical dilatation and uterine interventions. We suggest that woman are likely to consider the rates and severity of pain during uterine interventions when performed awake to be unacceptable in the absence of neuraxial blockade, which are unaltered by paracervical block.


Assuntos
Anestesia Local/métodos , Anestesia Obstétrica/métodos , Dilatação e Curetagem/efeitos adversos , Bloqueio Nervoso/métodos , Dor/prevenção & controle , Útero/cirurgia , Anestesia Local/efeitos adversos , Anestesia Obstétrica/efeitos adversos , Anestésicos Locais/administração & dosagem , Anestésicos Locais/efeitos adversos , Biópsia/efeitos adversos , Endométrio/patologia , Feminino , Humanos , Histeroscopia/efeitos adversos , Dor Pós-Operatória/prevenção & controle , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Cochrane Database Syst Rev ; (6): CD006623, 2013 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-23740693

RESUMO

BACKGROUND: Functional endoscopic sinus surgery (FESS) is a minimally invasive technique that is used to treat chronic sinusitis. Small bleeding areas can reduce operative visibility and result in destruction of surrounding structures. Deliberate hypotension (lowering the mean arterial blood pressure to between 50 and 65 mm Hg in normotensive patients) using a range of pharmacological agents during general anaesthesia reduces blood loss in many operations. OBJECTIVES: We aimed to compare the use of the intravenous anaesthetic agent propofol versus other techniques for deliberate hypotension during FESS with regard to blood loss and operative conditions. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 1), MEDLINE (1950 to April 2012), EMBASE (1980 to April 2012), LILACS (1982 to April 2012) and ISI Web of Science (1946 to April 2012). We also searched the reference lists of relevant articles and conference proceedings and contacted the authors of included trials. SELECTION CRITERIA: We sought all randomized controlled trials (RCTs) conducted to compare propofol with other techniques. Our primary outcome was total blood loss (TBL). Other outcomes included surgical field quality, operation time, mortality within 24 hour, complications and failure to reach target blood pressure. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted details of trial methodology and outcome data from reports of all trials considered eligible for inclusion. All analyses were made on an intention-to-treat basis where possible. When I(2) was < 40% and the P value from the Chi(2) test was > 0.10, we pooled data by using the fixed-effect model. Otherwise we pooled data by using the random-effects model. MAIN RESULTS: We included four studies with 278 participants in the review. Deliberate hypotension with propofol did not decrease TBL (millilitres) when compared with inhalation anaesthetics in either children or adults. Propofol improved the quality of the surgical field by less than one category on a scale from 0 (no bleeding) to 5 (severe bleeding) (mean difference (MD) 0.64 better with propofol, 95% confidence interval (CI) 0.37 to 0.91 better), but no difference in operation time was reported. Failure to lower blood pressure to target was less common in the propofol group (relative risk of failure with propofol (RR) 0.24, 95% CI 0.09 to 0.66). AUTHORS' CONCLUSIONS: Using propofol to achieve deliberate hypotension may improve the surgical field, but the effect is small. Deliberate hypotension with propofol did not decrease TBL and operation time. RCTs with good quality methodology and large sample size are required to investigate the effectiveness of deliberate hypotension with propofol for FESS.


Assuntos
Anestésicos Intravenosos , Perda Sanguínea Cirúrgica/prevenção & controle , Endoscopia/efeitos adversos , Hipotensão Controlada/métodos , Seios Paranasais/cirurgia , Propofol , Adulto , Criança , Endoscopia/métodos , Humanos , Duração da Cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
Cochrane Database Syst Rev ; (5): CD005637, 2013 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-23728655

RESUMO

BACKGROUND: The transcervical intrauterine route is commonly used for operative gynaecological procedures in women. The vagina is an area of the body that is abundant with normal bacterial flora. An operative procedure through the vagina may, therefore, be considered to have added potential for post-procedure infection. Prophylactic antibiotics may play a role in the prevention of post-procedure transcervical intrauterine infections. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. SEARCH METHODS: The search strategy was based on the Cochrane Menstrual Disorders and Subfertility Group (MDSG) search strategy. We searched the following databases: the Cochrane MDSG Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (to August 2012); MEDLINE (1946 to August 2012); EMBASE (1980 to August 2012); PsycINFO (to August 2012); CINAHL (to August 2012), Biological Abstracts (1966 to August 2012) and AMED (1966 to August 2012). SELECTION CRITERIA: We planned to include only truly randomised controlled trials that compared antibiotic prophylaxis with placebo or no treatment in order to prevent infectious complications after transcervical intrauterine procedures. Controlled clinical trials without randomisation and pseudo-randomised trials were excluded. DATA COLLECTION AND ANALYSIS: No data collection or analysis was done because no trials were eligible for inclusion in the review. MAIN RESULTS: The search did not identify any randomised controlled trials investigating the effect of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. AUTHORS' CONCLUSIONS: At this time, there are no randomised controlled trials that assess the effects of prophylactic antibiotics on infectious complications following transcervical intrauterine procedures. It is, therefore, not possible to draw any conclusions regarding the use of prophylactic antibiotics for the prevention of post-procedure transcervical intrauterine infections.


Assuntos
Antibioticoprofilaxia , Procedimentos Cirúrgicos em Ginecologia/métodos , Colo do Útero/cirurgia , Dilatação e Curetagem/efeitos adversos , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Humanos
18.
Cochrane Database Syst Rev ; (4): CD006014, 2013 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-23633332

RESUMO

BACKGROUND: Interval debulking surgery (IDS), following induction or neoadjuvant chemotherapy, may have a role in treating advanced epithelial ovarian cancer (stage III to IV) where primary debulking surgery is not an option. OBJECTIVES: To assess the effectiveness and complications of IDS for women with advanced stage epithelial ovarian cancer. SEARCH METHODS: We searched the Cochrane Gynaecological Cancer Group's Specialised Register to June 2012, the Cochrane Central Register of Controlled Trials (CENTRAL) 2012, Issue 6, MEDLINE to June 2012 and EMBASE to June 2012. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing survival of women with advanced epithelial ovarian cancer, who had IDS performed between cycles of chemotherapy after primary surgery with survival of women who had conventional treatment (primary debulking surgery and adjuvant chemotherapy). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Searches for additional information from study authors were attempted. We performed meta-analysis of overall and progression-free survival (PFS), using random-effects models. MAIN RESULTS: Three RCTs randomising 853 women, of whom 781 were evaluated, met the inclusion criteria. Meta-analysis of three trials for overall survival (OS) found no statistically significant difference between IDS and chemotherapy alone (hazard ratio (HR) = 0.80, 95% confidence interval (CI) 0.61 to 1.06, I² = 58%). Subgroup analysis for OS in two trials, where the primary surgery was not performed by gynaecologic oncologists or was less extensive, showed a benefit of IDS (HR = 0.68, 95% CI 0.53 to 0.87, I² = 0%). Meta-analysis of two trials for PFS found no statistically significant difference between IDS and chemotherapy alone (HR = 0.88, 95% CI 0.57 to 1.33, I² = 83%). Rates of toxic reactions to chemotherapy were similar in both arms (risk ratio = 1.19, 95% CI 0.53 to 2.66, I² = 0%), but little information was available for other adverse events or quality or life (QoL). AUTHORS' CONCLUSIONS: We found no conclusive evidence to determine whether IDS between cycles of chemotherapy would improve or decrease the survival rates of women with advanced ovarian cancer, compared with conventional treatment of primary surgery followed by adjuvant chemotherapy. IDS appeared to yield benefit only in women whose primary surgery was not performed by gynaecologic oncologists or was less extensive. Data on QoL and adverse events were inconclusive.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/cirurgia , Quimioterapia Adjuvante/mortalidade , Terapia Combinada/métodos , Feminino , Humanos , Terapia Neoadjuvante/métodos , Terapia Neoadjuvante/mortalidade , Neoplasias Ovarianas/mortalidade , Neoplasias Ovarianas/patologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão/métodos , Carga Tumoral/efeitos dos fármacos
19.
Cochrane Database Syst Rev ; (2): CD008994, 2013 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-23450594

RESUMO

BACKGROUND: Uterine fibroids are the most common premenopausal benign uterine tumours. Fibroids can cause symptoms including heavy menstrual bleeding, pelvic pressure and pain. Progestogens can be administered by various routes. Intramuscular injection of depot medroxyprogesterone acetate (DMPA) has dual actions (stimulatory or inhibitory) on fibroid cell growth. Progestogen-releasing intrauterine systems (IUS) decrease menstrual blood loss associated with fibroids by inducing endometrial atrophy and reduction of uterine fibroid size. Currently, their effectiveness for the treatment of uterine fibroids has not been evaluated. OBJECTIVES: To determine the effectiveness of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids. SEARCH METHODS: We searched the Menstrual Disorders and Subfertility Group Specialised Register (inception to 17 August 2012), CENTRAL (inception to 17 August 2012) and Database of Abstracts of Reviews of Effects (DARE) in The Cochrane Library, MEDLINE (inception to 17 August 2012), Ovid EMBASE (1 January 2010 to 17 August 2012), Ovid PsycINFO (inception to 17 August 2012), CINAHL database, and trials registers for ongoing and registered trials. SELECTION CRITERIA: All identified published or unpublished randomised controlled trials (RCTs) assessing the effect of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids. DATA COLLECTION AND ANALYSIS: We assessed all potentially eligible studies identified as a result of the search strategy. Two review authors extracted data from each included study using an agreed form and assessed the risk of bias. We resolved discrepancies through discussion. MAIN RESULTS: This review included three studies. However, data for progestogen-releasing intrauterine systems were available from only one study that compared 29 women with a levonorgestrel (LNG)-IUS versus 29 women with a combined oral contraceptive (COC) for treating uterine fibroids. There was a significant reduction of menstrual blood loss (MBL) in women receiving the LNG-IUS compared to the COC using the alkaline hematin test (mean difference (MD) 77.5%, 95% CI 71.3% to 83.67%, 58 women) and a pictorial assessment chart (PBAC) (MD 34.5%, 95% CI 14.9% to 54.1%, 58 women). The reduction in uterine fibroid size was significantly greater in the leuprorelin group at 16 weeks compared to the progestogen lynestrenol group (MD -15.93 mm, 95% CI -18.02 to -13.84 mm, 46 women). There was no RCT evaluating the effect of DMPA on uterine fibroids. AUTHORS' CONCLUSIONS: Progestogen-releasing intrauterine systems appear to reduce menstrual blood loss in premenopausal women with uterine fibroids. Oral progestogens did not reduce fibroid size or fibroid- related symptoms. However, there was a methodological limitation and the one included study with data had a small sample size. This evidence is insufficient to support the use of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids.


Assuntos
Antineoplásicos Hormonais/administração & dosagem , Dispositivos Intrauterinos Medicados , Leiomioma/tratamento farmacológico , Progestinas/administração & dosagem , Neoplasias Uterinas/tratamento farmacológico , Feminino , Humanos , Leiomioma/patologia , Leuprolida/administração & dosagem , Levanogestrel/administração & dosagem , Linestrenol/administração & dosagem , Acetato de Medroxiprogesterona/administração & dosagem , Menstruação/efeitos dos fármacos , Pré-Menopausa , Ensaios Clínicos Controlados Aleatórios como Assunto , Carga Tumoral/efeitos dos fármacos , Neoplasias Uterinas/patologia
20.
Asian Pac J Cancer Prev ; 14(11): 7011-6, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24377641

RESUMO

BACKGROUND: The liver fluke, Opisthorchis viverrini, and the associated incidence of subsequent cholangiocarcinoma (CCA) are still a public health problem in Thailand, and praziquantel (PZQ) remains the antihelminthic drug of choice for treatment. Evidence in hamsters shows that repeated infection and PZQ treatments could increase the risk of CCA. However, the existing evidence in humans is inconclusive regarding increased risk of CCA with frequency of PZQ intake. OBJECTIVES: To investigate the relationship between number of repeated PZQ treatments and CCA in patients with O viverrini infection. MATERIALS AND METHODS: The reviewed studies were searched in EMBASE, MEDLINE, ProQuest, PubMed and SCOPUS from inception to October, 2012 using prespecified keywords. The risk of bias (ROB) of included studies was independently assessed by two reviewers using a quality scale from the Newcastle-Ottawa Scale (NOS). Risk effect of PZQ was estimated as a pooled odds ratio (OR) with its 95% confidence interval (95%CI) in the random-effects model using DerSimonian and Laird's estimator. RESULTS: Three studies involving 637 patients were included. Based on the random effects model performed in two included studies of 237 patients, the association between PZQ treatments and CCA was not statistical significant with a pooled OR of 1.8 (95%CI; 0.81 to 4.16). CONCLUSIONS: The present systematic review and meta-analysis provides inconclusive evidence of risk effect of PZQ on increasing the risk of CCA and significant methodological limitations. Further research is urgently needed to address the shortcomings found in this review, especially the requirement for histological confirmation.


Assuntos
Neoplasias dos Ductos Biliares/induzido quimicamente , Ductos Biliares Intra-Hepáticos/efeitos dos fármacos , Colangiocarcinoma/induzido quimicamente , Opistorquíase/tratamento farmacológico , Praziquantel/efeitos adversos , Animais , Anti-Helmínticos/administração & dosagem , Anti-Helmínticos/efeitos adversos , Neoplasias dos Ductos Biliares/tratamento farmacológico , Ductos Biliares Intra-Hepáticos/parasitologia , Colangiocarcinoma/tratamento farmacológico , Colangiocarcinoma/parasitologia , Humanos , Opisthorchis/patogenicidade , Praziquantel/administração & dosagem , Prognóstico
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