Screening for Speech and Language Delay and Disorders in Children 5 Years or Younger: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Children with speech and language difficulties are at risk for learning and behavioral problems. Objective: To review the evidence on screening for speech and language delay or disorders in children 5 years or younger to inform the US Preventive Services Task Force. Data Sources: PubMed/MEDLINE, Cochrane Library, PsycInfo, ERIC, Linguistic and Language Behavior Abstracts (ProQuest), and trial registries through January 17, 2023; surveillance through November 24, 2023. Study Selection: English-language studies of screening test accuracy, trials or cohort studies comparing screening vs no screening; randomized clinical trials (RCTs) of interventions. Data Extraction and Synthesis: Dual review of abstracts, full-text articles, study quality, and data extraction; results were narratively summarized. Main Outcomes and Measures: Screening test accuracy, speech and language outcomes, school performance, function, quality of life, and harms. Results: Thirty-eight studies in 41 articles were included (N = 9006). No study evaluated the direct benefits of screening vs no screening. Twenty-one studies (n = 7489) assessed the accuracy of 23 different screening tools that varied with regard to whether they were designed to be completed by parents vs trained examiners, and to screen for global (any) language problems vs specific skills (eg, expressive language). Three studies assessing parent-reported tools for expressive language skills found consistently high sensitivity (range, 88%-93%) and specificity (range, 88%-85%). The accuracy of other screening tools varied widely. Seventeen RCTs (n = 1517) evaluated interventions for speech and language delay or disorders, although none enrolled children identified by routine screening in primary care. Two RCTs evaluating relatively intensive parental group training interventions (11 sessions) found benefit for different measures of expressive language skills, and 1 evaluating a less intensive intervention (6 sessions) found no difference between groups for any outcome. Two RCTs (n = 76) evaluating the Lidcombe Program of Early Stuttering Intervention delivered by speech-language pathologists featuring parent training found a 2.3% to 3.0% lower proportion of syllables stuttered at 9 months compared with the control group when delivered in clinic and via telehealth, respectively. Evidence on other interventions was limited. No RCTs reported on the harms of interventions. Conclusions and Relevance: No studies directly assessed the benefits and harms of screening. Some parent-reported screening tools for expressive language skills had reasonable accuracy for detecting expressive language delay. Group parent training programs for speech delay that provided at least 11 parental training sessions improved expressive language skills, and a stuttering intervention delivered by speech-language pathologists reduced stuttering frequency.

Methods to decrease blood loss during liver resection: a network meta-analysis.

BACKGROUND: Liver resection is a major surgery with significant mortality and morbidity. Specialists have tested various methods in attempts to limit blood loss, transfusion requirements, and morbidity during elective liver resection. These methods include different approaches (anterior versus conventional approach), use of autologous blood donation, cardiopulmonary interventions such as hypoventilation, low central venous pressure, different methods of parenchymal transection, different methods of management of the raw surface of the liver, different methods of vascular occlusion, and different pharmacological interventions. A surgeon typically uses only one of the methods from each of these seven categories. The optimal method to decrease blood loss and transfusion requirements in people undergoing liver resection is unknown. OBJECTIVES: To assess the effects of different interventions for decreasing blood loss and blood transfusion requirements during elective liver resection. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Science Citation Index Expanded to September 2015 to identify randomised clinical trials. We also searched trial registers and handsearched the references lists of identified trials. SELECTION CRITERIA: We included only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different methods of decreasing blood loss and blood transfusion requirements in people undergoing liver resection. DATA COLLECTION AND ANALYSIS: Two review authors independently identified trials and collected data. We assessed the risk of bias using Cochrane domains. We conducted a Bayesian network meta-analysis using the Markov chain Monte Carlo method in WinBUGS 1.4, following the guidelines of the National Institute for Health and Care Excellence Decision Support Unit guidance documents. We calculated the odds ratios (OR) with 95% credible intervals (CrI) for the binary outcomes, mean differences (MD) with 95% CrI for continuous outcomes, and rate ratios with 95% CrI for count outcomes, using a fixed-effect model or random-effects model according to model-fit. We assessed the evidence with GRADE. MAIN RESULTS: We identified 67 randomised clinical trials involving a total of 6197 participants. All the trials were at high risk of bias. A total of 5771 participants from 64 trials provided data for one or more outcomes included in this review. There was no evidence of differences in most of the comparisons, and where there was, these differences were in single trials, mostly of small sample size. We summarise only the evidence that was available in more than one trial below. Of the primary outcomes, the only one with evidence of a difference from more than one trial under the pair-wise comparison was in the number of adverse events (complications), which was higher with radiofrequency dissecting sealer than with the clamp-crush method (rate ratio 1.85, 95% CrI 1.07 to 3.26; 250 participants; 3 studies; very low-quality evidence). Among the secondary outcomes, the only differences we found from more than one trial under the pair-wise comparison were the following: blood transfusion (proportion) was higher in the low central venous pressure group than in the acute normovolemic haemodilution plus low central venous pressure group (OR 3.19, 95% CrI 1.56 to 6.95; 208 participants; 2 studies; low-quality evidence); blood transfusion quantity (red blood cells) was lower in the fibrin sealant group than in the control (MD -0.53 units, 95% CrI -1.00 to -0.07; 122 participants; 2; very low-quality evidence); blood transfusion quantity (fresh frozen plasma) was higher in the oxidised cellulose group than in the fibrin sealant group (MD 0.53 units, 95% CrI 0.36 to 0.71; 80 participants; 2 studies; very low-quality evidence); blood loss (MD -0.34 L, 95% CrI -0.46 to -0.22; 237 participants; 4 studies; very low-quality evidence), total hospital stay (MD -2.42 days, 95% CrI -3.91 to -0.94; 197 participants; 3 studies; very low-quality evidence), and operating time (MD -15.32 minutes, 95% CrI -29.03 to -1.69; 192 participants; 4 studies; very low-quality evidence) were lower with low central venous pressure than with control. For the other comparisons, the evidence for difference was either based on single small trials or there was no evidence of differences. None of the trials reported health-related quality of life or time needed to return to work. AUTHORS' CONCLUSIONS: Paucity of data meant that we could not assess transitivity assumptions and inconsistency for most analyses. When direct and indirect comparisons were available, network meta-analysis provided additional effect estimates for comparisons where there were no direct comparisons. However, the paucity of data decreases the confidence in the results of the network meta-analysis. Low-quality evidence suggests that liver resection using a radiofrequency dissecting sealer may be associated with more adverse events than with the clamp-crush method. Low-quality evidence also suggests that the proportion of people requiring a blood transfusion is higher with low central venous pressure than with acute normovolemic haemodilution plus low central venous pressure; very low-quality evidence suggests that blood transfusion quantity (red blood cells) was lower with fibrin sealant than control; blood transfusion quantity (fresh frozen plasma) was higher with oxidised cellulose than with fibrin sealant; and blood loss, total hospital stay, and operating time were lower with low central venous pressure than with control. There is no evidence to suggest that using special equipment for liver resection is of any benefit in decreasing the mortality, morbidity, or blood transfusion requirements (very low-quality evidence). Radiofrequency dissecting sealer should not be used outside the clinical trial setting since there is low-quality evidence for increased harm without any evidence of benefits. In addition, it should be noted that the sample size was small and the credible intervals were wide, and we cannot rule out considerable benefit or harm with a specific method of liver resection.

Medical Therapies for Uterine Fibroids - A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials.

BACKGROUND: Uterine fibroids are common, often symptomatic and a third of women need repeated time off work. Consequently 25% to 50% of women with fibroids receive surgical treatment, namely myomectomy or hysterectomy. Hysterectomy is the definitive treatment as fibroids are hormone dependent and frequently recurrent. Medical treatment aims to control symptoms in order to replace or delay surgery. This may improve the outcome of surgery and prevent recurrence. PURPOSE: To determine whether any medical treatment can be recommended in the treatment of women with fibroids about to undergo surgery and in those for whom surgery is not planned based on currently available evidence. STUDY SELECTION: Two authors independently identified randomised controlled trials (RCT) of all pharmacological treatments aimed at the treatment of fibroids from a list of references obtained by formal search of MEDLINE, EMBASE, Cochrane library, Science Citation Index, and ClinicalTrials.gov until December 2013. DATA EXTRACTION: Two authors independently extracted data from identified studies. DATA SYNTHESIS: A Bayesian network meta-analysis was performed following the National Institute for Health and Care Excellence-Decision Support Unit guidelines. Odds ratios, rate ratios, or mean differences with 95% credible intervals (CrI) were calculated. RESULTS AND LIMITATIONS: A total of 75 RCT met the inclusion criteria, 47 of which were included in the network meta-analysis. The overall quality of evidence was very low. The network meta-analysis showed differing results for different outcomes. CONCLUSIONS: There is currently insufficient evidence to recommend any medical treatment in the management of fibroids. Certain treatments have future promise however further, well designed RCTs are needed.

A Cochrane systematic review and network meta-analysis comparing treatment strategies aiming to decrease blood loss during liver resection.

INTRODUCTION: Intraoperative haemorrhage remains one of the major risks during liver resection, and perioperative blood loss and blood transfusion are important factors affecting perioperative morbidity and mortality. The aim of this study is to compare treatment strategies aiming to decrease blood loss during hepatectomy. METHODS: A systematic review of the literature was performed to identify randomised controlled trials reporting on the method of vascular occlusion, parenchymal transection, and management of the cut surface during liver resection. A Bayesian network meta-analysis was performed using WinBUGS. RESULTS: Seven trials reporting on 496 participants randomised to seven treatment strategies were analysed. Continuous vascular occlusion resulted in lower blood loss compared to no vascular occlusion when parenchymal transection was performed with clamp-crush and no fibrin sealant was used for the cut surface. People undergoing liver resection by continuous vascular occlusion had decreased amounts of blood transfused than people with intermittent vascular occlusion when parenchymal transection was performed with clamp-crush and no fibrin sealant. There was no significant difference in proportion of people transfused, mortality, or hospital stay between the different strategies. There were significantly more serious adverse events when surgery was performed using radiofrequency dissecting sealer compared with standard clamp-crush method in the absence of vascular occlusion and fibrin sealant. CONCLUSIONS: Continuous vascular occlusion during hepatectomy results in decreased blood loss and decreased blood transfusion requirements. Further studies are needed to compare treatment strategies aiming to decrease blood loss, defined by their method of vascular occlusion, parenchymal transection, and management of the cut surface.

Pharmacological interventions for prevention or treatment of postoperative pain in people undergoing laparoscopic cholecystectomy.

BACKGROUND: While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day-surgery and overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of different pharmacological interventions such as non-steroidal anti-inflammatory drugs, opioids, and anticonvulsant analgesics in people undergoing laparoscopic cholecystectomy is unknown. OBJECTIVES: To assess the benefits and harms of different analgesics in people undergoing laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal (WHO ICTRP) to March 2013 to identify randomised clinical trials of relevance to this review. SELECTION CRITERIA: We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different pharmacological interventions with no intervention or inactive controls for outcomes related to benefit in this review. We considered comparative non-randomised studies with regards to treatment-related harms. We also considered trials that compared one class of drug with another class of drug for this review. DATA COLLECTION AND ANALYSIS: Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). MAIN RESULTS: We included 25 trials with 2505 participants randomised to the different pharmacological agents and inactive controls. All the trials were at unclear risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Participants were allowed to take additional analgesics as required in 24 of the trials. The pharmacological interventions in all the included trials were aimed at preventing pain after laparoscopic cholecystectomy. There were considerable differences in the pharmacological agents used and the methods of administration. The estimated effects of the intervention on the proportion of participants who were discharged as day-surgery, the length of hospital stay, or the time taken to return to work were imprecise in all the comparisons in which these outcomes were reported (very low quality evidence). There was no mortality in any of the groups in the two trials that reported mortality (183 participants, very low quality evidence). Differences in serious morbidity outcomes between the groups were imprecise across all the comparisons (very low quality evidence). None of the trials reported patient quality of life or time taken to return to normal activity. The pain at 4 to 8 hours was generally reduced by about 1 to 2 cm on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). The pain at 9 to 24 hours was generally reduced by about 0.5 cm (a modest reduction) on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). AUTHORS' CONCLUSIONS: There is evidence of very low quality that different pharmacological agents including non-steroidal anti-inflammatory drugs, opioid analgesics, and anticonvulsant analgesics reduce pain scores in people at low anaesthetic risk undergoing elective laparoscopic cholecystectomy. However, the decision to use these drugs has to weigh the clinically small reduction in pain against uncertain evidence of serious adverse events associated with many of these agents. Further randomised clinical trials of low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.

Methods to decrease blood loss during liver resection: a network meta-analysis.

BACKGROUND: Liver resection is a major surgery with significant mortality and morbidity. Various methods have been attempted to decrease blood loss and morbidity during elective liver resection. These methods include different methods of vascular occlusion, parenchymal transection, and management of the cut surface of the liver. A surgeon typically uses only one of the methods from each of these three categories. Together, one can consider this combination as a treatment strategy. The optimal treatment strategy for liver resection is unknown. OBJECTIVES: To assess the comparative benefits and harms of different treatment strategies that aim to decrease blood loss during elective liver resection. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to July 2012 to identify randomised clinical trials. We also handsearched the references lists of identified trials. SELECTION CRITERIA: We included only randomised clinical trials (irrespective of language, blinding, or publication status) where the method of vascular occlusion, parenchymal transection, and management of the cut surface were clearly reported, and where people were randomly assigned to different treatment strategies based on different combinations of the three categories (vascular occlusion, parenchymal transection, cut surface). DATA COLLECTION AND ANALYSIS: Two review authors identified trials and collected data independently. We assessed the risk of bias using The Cochrane Collaboration's methodology. We conducted a Bayesian network meta-analysis using the Markov chain Monte Carlo method in WinBUGS 1.4 following the guidelines of the National Institute for Health and Care Excellence Decision Support Unit guidance documents. We calculated the odds ratios (OR) with 95% credible intervals (CrI) (which are similar to confidence intervals in the frequentist approach for meta-analysis) for the binary outcomes and mean differences (MD) with 95% CrI for continuous outcomes using a fixed-effect model or random-effects model according to model-fit. MAIN RESULTS: We identified nine trials with 617 participants that met our inclusion criteria. Interventions in the trials included three different options for vascular occlusion, four for parenchymal transection, and two for management of the cut liver surface. These interventions were combined in different ways in the trials giving 11 different treatment strategies. However, we were only able to include 496 participants randomised to seven different treatment strategies from seven trials in our network meta-analysis, because the treatment strategies from the trials that used fibrin sealant for management of the raw liver surface could not be connected to the network for any outcomes. Thus, the trials included in the network meta-analysis varied only in their approaches to vascular exclusion and parenchymal transection and none used fibrin sealant. All the trials were of high risk of bias and the quality of evidence was very low for all the outcomes. The differences in mortality between the different strategies was imprecise (seven trials; seven treatment strategies; 496 participants). Five trials (six strategies; 406 participants) reported serious adverse events. There was an increase in the proportion of people with serious adverse events when surgery was performed using radiofrequency dissecting sealer compared with the standard clamp-crush method in the absence of vascular occlusion and fibrin sealant. The OR for the difference in proportion was 7.13 (95% CrI 1.77 to 28.65; 15/49 (adjusted proportion 24.9%) in radiofrequency dissecting sealer group compared with 6/89 (6.7%) in the clamp-crush method). The differences in serious adverse events between the other groups were imprecise. There was a high probability that 'no vascular occlusion with clamp-crush method and no fibrin' and 'intermittent vascular occlusion with Cavitron ultrasonic surgical aspirator and no fibrin' are better than other treatments with regards to serious adverse events. Quality of life was not reported in any of the trials.The differences in the proportion of people requiring blood transfusion was imprecise (six trials; seven treatments; 446 participants). Two trials (three treatments; 155 participants) provided data for quantity of blood transfused. People undergoing liver resection by intermittent vascular occlusion had higher amounts of blood transfused than people with continuous vascular occlusion when the parenchymal transection was carried out with the clamp-crush method and no fibrin sealant was used for the cut surface (MD 1.2 units; 95% CrI 0.08 to 2.32). The differences in the other comparisons were imprecise (very low quality evidence). Three trials (four treatments; 281 participants) provided data for operative blood loss. People undergoing liver resection using continuous vascular occlusion had lower blood loss than people with no vascular occlusion when the parenchymal transection was carried out with clamp-crush method and no fibrin sealant was used for the cut surface (MD -130.9 mL; 95% CrI -255.9 to -5.9). None of the trials reported the proportion of people with major blood loss.The differences in the length of hospital stay (six trials; seven treatments; 446 participants) and intensive therapy unit stay (four trials; six treatments; 261 participants) were imprecise. Four trials (four treatments; 245 participants) provided data for operating time. Liver resection by intermittent vascular occlusion took longer than liver resection performed with no vascular occlusion when the parenchymal transection was carried out with Cavitron ultrasonic surgical aspirator and no fibrin sealant was used for the cut surface (MD 49.6 minutes; 95% CrI 29.8 to 69.4). The differences in the operating time between the other comparisons were imprecise. None of the trials reported the time needed to return to work. AUTHORS' CONCLUSIONS: Very low quality evidence suggested that liver resection using a radiofrequency dissecting sealer without vascular occlusion or fibrin sealant may increase serious adverse events and this should be evaluated in further randomised clinical trials. The risk of serious adverse events with liver resection using no special equipment compared with more complex methods requiring special equipment was uncertain due to the very low quality of the evidence. The credible intervals were wide and considerable benefit or harm with a specific method of liver resection cannot be ruled out.

Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy.

BACKGROUND: A pneumoperitoneum of 12 to 16 mm Hg is used for laparoscopic cholecystectomy. Lower pressures are claimed to be safe and effective in decreasing cardiopulmonary complications and pain. OBJECTIVES: To assess the benefits and harms of low pressure pneumoperitoneum compared with standard pressure pneumoperitoneum in people undergoing laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013 to identify randomised trials,using search strategies. SELECTION CRITERIA: We considered only randomised clinical trials, irrespective of language, blinding, or publication status for inclusion in the review. DATA COLLECTION AND ANALYSIS: Two review authors independently identified trials and independently extracted data. We calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) using both fixed-effect and random-effects models with RevMan 5 based on available case analysis. MAIN RESULTS: A total of 1092 participants randomly assigned to the low pressure group (509 participants) and the standard pressure group (583 participants) in 21 trials provided information for this review on one or more outcomes. Three additional trials comparing low pressure pneumoperitoneum with standard pressure pneumoperitoneum (including 179 participants) provided no information for this review. Most of the trials included low anaesthetic risk participants undergoing elective laparoscopic cholecystectomy. One trial including 140 participants was at low risk of bias. The remaining 20 trials were at high risk of bias. The overall quality of evidence was low or very low. No mortality was reported in either the low pressure group (0/199; 0%) or the standard pressure group (0/235; 0%) in eight trials that reported mortality. One participant experienced the outcome of serious adverse events (low pressure group 1/179, 0.6%; standard pressure group 0/215, 0%; seven trials; 394 participants; RR 3.00; 95% CI 0.14 to 65.90; very low quality evidence). Quality of life, return to normal activity, and return to work were not reported in any of the trials. The difference between groups in the conversion to open cholecystectomy was imprecise (low pressure group 2/269, adjusted proportion 0.8%; standard pressure group 2/287, 0.7%; 10 trials; 556 participants; RR 1.18; 95% CI 0.29 to 4.72; very low quality evidence) and was compatible with an increase, a decrease, or no difference in the proportion of conversion to open cholecystectomy due to low pressure pneumoperitoneum. No difference in the length of hospital stay was reported between the groups (five trials; 415 participants; MD -0.30 days; 95% CI -0.63 to 0.02; low quality evidence). Operating time was about two minutes longer in the low pressure group than in the standard pressure group (19 trials; 990 participants; MD 1.51 minutes; 95% CI 0.07 to 2.94; very low quality evidence). AUTHORS' CONCLUSIONS: Laparoscopic cholecystectomy can be completed successfully using low pressure in approximately 90% of people undergoing laparoscopic cholecystectomy. However, no evidence is currently available to support the use of low pressure pneumoperitoneum in low anaesthetic risk patients undergoing elective laparoscopic cholecystectomy. The safety of low pressure pneumoperitoneum has to be established. Further well-designed trials are necessary, particularly in people with cardiopulmonary disorders who undergo laparoscopic cholecystectomy.

Formal education of patients about to undergo laparoscopic cholecystectomy.

BACKGROUND: Generally, before being operated on, patients will be given informal information by the healthcare providers involved in the care of the patients (doctors, nurses, ward clerks, or healthcare assistants). This information can also be provided formally in different formats including written information, formal lectures, or audio-visual recorded information. OBJECTIVES: To compare the benefits and harms of formal preoperative patient education for patients undergoing laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2013), MEDLINE, EMBASE, and Science Citation Index Expanded to March 2013. SELECTION CRITERIA: We included only randomised clinical trials irrespective of language and publication status. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data. We planned to calculate the risk ratio with 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) with 95% CI for continuous outcomes based on intention-to-treat analyses when data were available. MAIN RESULTS: A total of 431 participants undergoing elective laparoscopic cholecystectomy were randomised to formal patient education (215 participants) versus standard care (216 participants) in four trials. The patient education included verbal education, multimedia DVD programme, computer-based multimedia programme, and Power Point presentation in the four trials. All the trials were of high risk of bias. One trial including 212 patients reported mortality. There was no mortality in either group in this trial. None of the trials reported surgery-related morbidity, quality of life, proportion of patients discharged as day-procedure laparoscopic cholecystectomy, the length of hospital stay, return to work, or the number of unplanned visits to the doctor. There were insufficient details to calculate the mean difference and 95% CI for the difference in pain scores at 9 to 24 hours (1 trial; 93 patients); and we did not identify clear evidence of an effect on patient knowledge (3 trials; 338 participants; SMD 0.19; 95% CI -0.02 to 0.41; very low quality evidence), patient satisfaction (2 trials; 305 patients; SMD 0.48; 95% CI -0.42 to 1.37; very low quality evidence), or patient anxiety (1 trial; 76 participants; SMD -0.37; 95% CI -0.82 to 0.09; very low quality evidence) between the two groups.A total of 173 participants undergoing elective laparoscopic cholecystectomy were randomised to electronic consent with repeat-back (patients repeating back the information provided) (92 participants) versus electronic consent without repeat-back (81 participants) in one trial of high risk of bias. The only outcome reported in this trial was patient knowledge. The effect on patient knowledge between the patient education with repeat-back versus patient education without repeat-back groups was imprecise and based on 1 trial of 173 participants; SMD 0.07; 95% CI -0.22 to 0.37; very low quality evidence). AUTHORS' CONCLUSIONS: Due to the very low quality of the current evidence, the effects of formal patient education provided in addition to the standard information provided by doctors to patients compared with standard care remain uncertain. Further well-designed randomised clinical trials of low risk of bias are necessary.

Fewer-than-four ports versus four ports for laparoscopic cholecystectomy.

BACKGROUND: Traditionally, laparoscopic cholecystectomy is performed using two 10-mm ports and two 5-mm ports. Recently, a reduction in the number of ports has been suggested as a modification of the standard technique with a view to decreasing pain and improving cosmesis. The safety and effectiveness of using fewer-than-four ports has not yet been established. OBJECTIVES: To assess the benefits (such as improvement in cosmesis and earlier return to activity) and harms (such as increased complications) of using fewer-than-four ports (fewer-than-four-ports laparoscopic cholecystectomy) versus four ports in people undergoing laparoscopic cholecystectomy for any reason (symptomatic gallstones, acalculous cholecystitis, gallbladder polyp, or any other condition). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2013), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal to September 2013. SELECTION CRITERIA: We included all randomised clinical trials comparing fewer-than-four ports versus four ports, that is, with standard laparoscopic cholecystectomy that is performed with two ports of at least 10-mm incision and two ports of at least 5-mm incision. DATA COLLECTION AND ANALYSIS: Two review authors independently identified the trials and extracted the data. We analysed the data using both the fixed-effect and the random-effects models. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis, whenever possible. MAIN RESULTS: We found nine trials with 855 participants that randomised participants to fewer-than-four-ports laparoscopic cholecystectomy (n = 427) versus four-port laparoscopic cholecystectomy (n = 428). Most trials included low anaesthetic risk participants undergoing elective laparoscopic cholecystectomy. Seven of the nine trials used a single port laparoscopic cholecystectomy and the remaining two trials used three-port laparoscopic cholecystectomy as the experimental intervention. Only one trial including 70 participants had low risk of bias. Fewer-than-four-ports laparoscopic cholecystectomy could be completed successfully in more than 90% of participants in most trials. The remaining participants were mostly converted to four-port laparoscopic cholecystectomy but some participants had to undergo open cholecystectomy.There was no mortality in either group in the seven trials that reported mortality (318 participants in fewer-than-four-ports laparoscopic cholecystectomy group and 316 participants in four-port laparoscopic cholecystectomy group). The proportion of participants with serious adverse events was low in both treatment groups and the estimated RR was compatible with a reduction and substantial increased risk with the fewer-than-four-ports group (6/318 (1.9%)) and four-port laparoscopic cholecystectomy group (0/316 (0%)) (RR 3.93; 95% CI 0.86 to 18.04; 7 trials; 634 participants; very low quality evidence). The estimated difference in the quality of life (measured between 10 and 30 days) was imprecise (standardised mean difference (SMD) 0.18; 95% CI -0.05 to 0.42; 4 trials; 510 participants; very low quality evidence), as was the proportion of participants in whom the laparoscopic cholecystectomy had to be converted to open cholecystectomy between the groups (fewer-than-four ports 3/289 (adjusted proportion 1.2%) versus four port: 5/292 (1.7%); RR 0.68; 95% CI 0.19 to 2.35; 5 trials; 581 participants; very low quality evidence). The fewer-than-four-ports laparoscopic cholecystectomy took 14 minutes longer to complete (MD 14.44 minutes; 95% CI 5.95 to 22.93; 9 trials; 855 participants; very low quality evidence). There was no clear difference in hospital stay between the groups (MD -0.01 days; 95% CI -0.28 to 0.26; 6 trials; 731 participants) or in the proportion of participants discharged as day surgery (RR 0.92; 95% CI 0.70 to 1.22; 1 trial; 50 participants; very low quality evidence) between the two groups. The times taken to return to normal activity and work were shorter by two days in the fewer-than-four-ports group compared with four-port laparoscopic cholecystectomy (return to normal activity: MD -1.20 days; 95% CI -1.58 to -0.81; 2 trials; 325 participants; very low quality evidence; return to work: MD -2.00 days; 95% CI -3.31 to -0.69; 1 trial; 150 participants; very low quality evidence). There was no significant difference in cosmesis scores at 6 to 12 months between the two groups (SMD 0.37; 95% CI -0.10 to 0.84; 2 trials; 317 participants; very low quality evidence). AUTHORS' CONCLUSIONS: There is very low quality evidence that is insufficient to determine whether there is any significant clinical benefit in using fewer-than-four-ports laparoscopic cholecystectomy compared with four-port laparoscopic cholecystectomy. The safety profile of using fewer-than-four ports is yet to be established and fewer-than-four-ports laparoscopic cholecystectomy should be reserved for well-designed randomised clinical trials.

Anaesthetic regimens for day-procedure laparoscopic cholecystectomy.

BACKGROUND: Day surgery involves admission of selected patients to hospital for a planned surgical procedure with the patients returning home on the same day. An anaesthetic regimen usually involves a combination of an anxiolytic, an induction agent, a maintenance agent, a method of maintaining the airway (laryngeal mask versus endotracheal intubation), and a muscle relaxant. The effect of anaesthesia may continue after the completion of surgery and can delay discharge. Various regimens of anaesthesia have been suggested for day-procedure laparoscopic cholecystectomy. OBJECTIVES: To compare the benefits and harms of different anaesthetic regimens (risks of mortality and morbidity, measures of recovery after surgery) in patients undergoing day-procedure laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 10, 2013), MEDLINE (PubMed) (1987 to November 2013), EMBASE (OvidSP) (1987 to November 2013), Science Citation Index Expanded (ISI Web of Knowledge) (1987 to November 2013), LILACS (Virtual Health Library) (1987 to November 2013), metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) (November 2013), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal (November 2013), and ClinicalTrials.gov (November 2013). SELECTION CRITERIA: We included randomized clinical trials comparing different anaesthetic regimens during elective day-procedure laparoscopic cholecystectomy (irrespective of language or publication status). DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for inclusion and independently extracted the data. We calculated the risk ratio, rate ratio or mean difference with 95% confidence intervals based on intention-to-treat or available data analysis. MAIN RESULTS: We included 11 trials involving 1069 participants at low anaesthetic risk. The sample size varied from 40 to 300 participants. We included 23 comparisons. All trials were at a high risk of bias. We were unable to perform a meta-analysis because there were no two trials involving the same comparison. Primary outcomes included perioperative mortality, serious morbidity and proportion of patients who were discharged on the same day. There were no perioperative deaths or serious adverse events in either group in the only trial that reported this information (0/60). There was no clear evidence of a difference in the proportion of patients who were discharged on the same day between any of the comparisons. Overall, 472/554 patients (85%) included in this review were discharged as day-procedure laparoscopic cholecystectomy patients. Secondary outcomes included hospital readmissions, health-related quality of life, pain, return to activity and return to work. There was no clear evidence of a difference in hospital readmissions within 30 days in the only comparison in which this outcome was reported. One readmission was reported in the 60 patients (2%) in whom this outcome was assessed. Quality of life was not reported in any of the trials. There was no clear evidence of a difference in the pain intensity, measured by a visual analogue scale, between comparators in the only trial which reported the pain intensity at between four and eight hours after surgery. Times to return to activity and return to work were not reported in any of the trials. AUTHORS' CONCLUSIONS: There is currently insufficient evidence to conclude that one anaesthetic regimen for day-procedure laparoscopic cholecystectomy is to be preferred over another. However, the data are sparse (that is, there were few trials under each comparison and the trials had few participants) and further well designed randomized trials at low risk of bias and which are powered to measure differences in clinically important outcomes are necessary to determine the optimal anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world.

Miniports versus standard ports for laparoscopic cholecystectomy.

BACKGROUND: In conventional (standard) port laparoscopic cholecystectomy, four abdominal ports (two of 10 mm diameter and two of 5 mm diameter) are used. Recently, use of smaller ports, miniports, have been reported. OBJECTIVES: To assess the benefits and harms of miniport (defined as ports smaller than the standard ports) laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013 to identify randomised clinical trials of relevance to this review. SELECTION CRITERIA: Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing miniport versus standard port laparoscopic cholecystectomy were considered for the review. DATA COLLECTION AND ANALYSIS: Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using RevMan analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI). MAIN RESULTS: We included 12 trials with 734 patients randomised to miniport laparoscopic cholecystectomy (380 patients) versus standard laparoscopic cholecystectomy (351 patients). Only one trial which included 70 patients was of low risk of bias. Miniport laparoscopic cholecystectomy could be completed successfully in more than 80% of patients in most trials. The remaining patients were mostly converted to standard port laparoscopic cholecystectomy but some were also converted to open cholecystectomy. These patients were included for the outcome conversion to open cholecystectomy but excluded from other outcomes. Accordingly, the results of the other outcomes are on 343 patients in the miniport laparoscopic cholecystectomy group and 351 patients in the standard port laparoscopic cholecystectomy group, and therefore the results have to be interpreted with extreme caution.There was no mortality in the seven trials that reported mortality (0/194 patients in miniport laparoscopic cholecystectomy versus 0/203 patients in standard port laparoscopic cholecystectomy). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the proportion of patients who developed serious adverse events (eight trials; 460 patients; RR 0.33; 95% CI 0.04 to 3.08) (miniport laparoscopic cholecystectomy: 1/226 (adjusted proportion 0.4%) versus standard laparoscopic cholecystectomy: 3/234 (1.3%); quality of life at 10 days after surgery (one trial; 70 patients; SMD -0.20; 95% CI -0.68 to 0.27); or in whom the laparoscopic operation had to be converted to open cholecystectomy (11 trials; 670 patients; RR 1.23; 95% CI 0.44 to 3.45) (miniport laparoscopic cholecystectomy: 8/351 (adjusted proportion 2.3%) versus standard laparoscopic cholecystectomy 6/319 (1.9%)). Miniport laparoscopic cholecystectomy took five minutes longer to complete than standard laparoscopic cholecystectomy (12 trials; 695 patients; MD 4.91 minutes; 95% CI 2.38 to 7.44). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the length of hospital stay (six trials; 351 patients; MD -0.00 days; 95% CI -0.12 to 0.11); the time taken to return to activity (one trial; 52 patients; MD 0.00 days; 95% CI -0.31 to 0.31); or in the time taken for the patient to return to work (two trials; 187 patients; MD 0.28 days; 95% CI -0.44 to 0.99) between the groups. There was no significant difference in the cosmesis scores at six months to 12 months after surgery between the two groups (two trials; 152 patients; SMD 0.13; 95% CI -0.19 to 0.46). AUTHORS' CONCLUSIONS: Miniport laparoscopic cholecystectomy can be completed successfully in more than 80% of patients. There appears to be no advantage of miniport laparoscopic cholecystectomy in terms of decreasing mortality, morbidity, hospital stay, return to activity, return to work, or improving cosmesis. On the other hand, there is a modest increase in operating time after miniport laparoscopic cholecystectomy compared with standard port laparoscopic cholecystectomy and the safety of miniport laparoscopic cholecystectomy is yet to be established. Miniport laparoscopic cholecystectomy cannot be recommended routinely outside well-designed randomised clinical trials. Further trials of low risks of bias and low risks of random errors are necessary.

Day-surgery versus overnight stay surgery for laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy is used to manage symptomatic gallstones. There is considerable controversy regarding whether it should be done as day-surgery or as an overnight stay surgery with regards to patient safety. OBJECTIVES: To assess the impact of day-surgery versus overnight stay laparoscopic cholecystectomy on patient-oriented outcomes such as mortality, severe adverse events, and quality of life. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and mRCT until September 2012. SELECTION CRITERIA: We included randomised clinical trials comparing day-surgery versus overnight stay surgery for laparoscopic cholecystectomy, irrespective of language or publication status. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for inclusion and independently extracted the data. We analysed the data with both the fixed-effect and the random-effects models using Review Manager 5 analysis. We calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) based on intention-to-treat or available case analysis. MAIN RESULTS: We identified a total of six trials at high risk of bias involving 492 participants undergoing day-case laparoscopic cholecystectomy (n = 239) versus overnight stay laparoscopic cholecystectomy (n = 253) for symptomatic gallstones. The number of participants in each trial ranged from 28 to 150. The proportion of women in the trials varied between 74% and 84%. The mean or median age in the trials varied between 40 and 47 years.With regards to primary outcomes, only one trial reported short-term mortality. However, the trial stated that there were no deaths in either of the groups. We inferred from the other outcomes that there was no short-term mortality in the remaining trials. Long-term mortality was not reported in any of the trials. There was no significant difference in the rate of serious adverse events between the two groups (4 trials; 391 participants; 7/191 (weighted rate 1.6%) in the day-surgery group versus 1/200 (0.5%) in the overnight stay surgery group; rate ratio 3.24; 95% CI 0.74 to 14.09). There was no significant difference in quality of life between the two groups (4 trials; 333 participants; SMD -0.11; 95% CI -0.33 to 0.10).There was no significant difference between the two groups regarding the secondary outcomes of our review: pain (3 trials; 175 participants; MD 0.02 cm visual analogue scale score; 95% CI -0.69 to 0.73); time to return to activity (2 trials, 217 participants; MD -0.55 days; 95% CI -2.18 to 1.08); and return to work (1 trial, 74 participants; MD -2.00 days; 95% CI -10.34 to 6.34). No significant difference was seen in hospital readmission rate (5 trials; 464 participants; 6/225 (weighted rate 0.5%) in the day-surgery group versus 5/239 (2.1%) in the overnight stay surgery group (rate ratio 1.25; 95% CI 0.43 to 3.63) or in the proportion of people requiring hospital readmissions (3 trials; 290 participants; 5/136 (weighted proportion 3.5%) in the day-surgery group versus 5/154 (3.2%) in the overnight stay surgery group; RR 1.09; 95% CI 0.33 to 3.60). No significant difference was seen in the proportion of failed discharge (failure to be discharged as planned) between the two groups (5 trials; 419 participants; 42/205 (weighted proportion 19.3%) in the day-surgery group versus 43/214 (20.1%) in the overnight stay surgery group; RR 0.96; 95% CI 0.65 to 1.41). For all outcomes except pain, the accrued information was far less than the diversity-adjusted required information size to exclude random errors. AUTHORS' CONCLUSIONS: Day-surgery appears just as safe as overnight stay surgery in laparoscopic cholecystectomy. Day-surgery does not seem to result in improvement in any patient-oriented outcomes such as return to normal activity or earlier return to work. The randomised clinical trials backing these statements are weakened by risks of systematic errors (bias) and risks of random errors (play of chance). More randomised clinical trials are needed to assess the impact of day-surgery laparoscopic cholecystectomy on the quality of life as well as other outcomes of patients.

Cardiopulmonary interventions to decrease blood loss and blood transfusion requirements for liver resection.

BACKGROUND: Blood loss during liver resection is considered one of the most important factors affecting the peri-operative outcomes of patients undergoing liver resection. OBJECTIVES: To determine the benefits and harms of cardiopulmonary interventions to decrease blood loss and to decrease allogeneic blood transfusion requirements in patients undergoing liver resections. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until January 2012 to identify randomised trials. SELECTION CRITERIA: We included all randomised clinical trials comparing various cardiopulmonary interventions aimed at decreasing blood loss and allogeneic blood transfusion requirements in patients undergoing liver resection. Trials were included irrespective of whether they included major or minor liver resections of normal or cirrhotic livers, vascular occlusion was used or not, and irrespective of the reason for liver resection. DATA COLLECTION AND ANALYSIS: Two authors independently identified trials for inclusion and independently extracted data. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) based on intention-to-treat analysis or available case analysis. For dichotomous outcomes with only one trial included under the outcome, we performed the Fisher's exact test. MAIN RESULTS: Ten trials involving 617 patients satisfied the inclusion criteria. The interventions included low central venous pressure (CVP), autologous blood donation, haemodilution, haemodilution with controlled hypotension, and hypoventilation. Only one or two trials were included under most comparisons. All trials had a high risk of bias. There was no significant difference in the peri-operative mortality in any of the comparisons: low CVP versus no intervention (3 trials, 0/88 (0%) patients in the low CVP group versus 1/89 (1.1%) patients in the no intervention group); autologous blood donation versus no intervention (1 trial, 0/40 (0%) versus 0/39 (0%)); haemodilution versus no intervention (2 trials, 1/73 (1.4%) versus 3/77 (3.9%) in one of these trials); haemodilution with controlled hypotension versus no intervention (1 trial, 0/10 (0%) versus 0/10 (0%)); haemodilution with bovine haemoglobin (HBOC-201) versus haemodilution with hydroxy ethyl starch (HES) (1 trial, 1/6 (16.7%) versus 0/6 (0%)); hypoventilation versus no intervention (1 trial, 0/40 (0%) versus 0/39 (0%)). None of the trials reported long-term survival or quality of life. The risk ratio of requiring allogeneic blood transfusion was significantly lower in the haemodilution versus no intervention groups (3 trials, 16/115 (weighted proportion = 14.2%) versus 41/118 (34.7%), RR 0.41 (95% CI 0.25 to 0.66), P = 0.0003); and for haemodilution with controlled hypotension versus no intervention (1 trial, 0/10 (0%) versus 10/10 (100%), P < 0.0001). There were no significant differences in the allogeneic transfusion requirements in the other comparisons which reported this outcome, such as low CVP versus no intervention, autologous blood donation versus control, and hypoventilation versus no intervention. AUTHORS' CONCLUSIONS: None of the interventions seemed to decrease peri-operative morbidity or offer any long-term survival benefit. Haemodilution shows promise in the reduction of blood transfusion requirements in liver resection surgery. However, there is a high risk of type I (erroneously concluding that an intervention is beneficial when it is actually not beneficial) and type II errors (erroneously concluding that an intervention is not beneficial when it is actually beneficial) because of the few trials included, the small sample size in each trial, and the high risk of bias in the trials. Further randomised clinical trials with low risk of bias and random errors that assess clinically important outcomes such as peri-operative mortality are necessary to assess any cardiopulmonary interventions aimed at decreasing blood loss and blood transfusion requirements in patients undergoing liver resections. Trials need to be designed to assess the effect of a combination of different interventions in liver resections.