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BACKGROUND: Increased protein provision might ameliorate muscle wasting and improve long-term outcomes in critically ill patients. The aim of the PRECISe trial was to assess whether higher enteral protein provision (ie, 2·0 g/kg per day) would improve health-related quality of life and functional outcomes in critically ill patients who were mechanically ventilated compared with standard enteral protein provision (ie, 1·3 g/kg per day). METHODS: The PRECISe trial was an investigator-initiated, double-blinded, multicentre, parallel-group, randomised controlled trial in five Dutch hospitals and five Belgian hospitals. Inclusion criteria were initiation of invasive mechanical ventilation within 24 h of intensive care unit (ICU) admission and an expected duration of invasive ventilation of 3 days or longer. Exclusion criteria were contraindications for enteral nutrition, moribund condition, BMI less than 18 kg/m2, kidney failure with a no dialysis code, or hepatic encephalopathy. Patients were randomly assigned to one of four randomisation labels, corresponding with two study groups (ie, standard or high protein; two labels per group) in a 1:1:1:1 ratio through an interactive web-response system. Randomisation was done via random permuted-block randomisation in varying block sizes of eight and 12, stratified by centre. Participants, care providers, investigators, outcome assessors, data analysts, and the independent data safety monitoring board were all blinded to group allocation. Patients received isocaloric enteral feeds that contained 1·3 kcal/mL and 0·06 g of protein/mL (ie, standard protein) or 1·3 kcal/mL and 0·10 g of protein/mL (ie, high protein). The study-nutrition intervention was limited to the time period during the patient's ICU stay in which they required enteral feeding, with a maximum of 90 days. The primary outcome was EuroQoL 5-Dimension 5-level (EQ-5D-5L) health utility score at 30 days, 90 days, and 180 days after randomisation, adjusted for baseline EQ-5D-5L health utility score. This trial was registered with ClinicalTrials.gov (NCT04633421) and is closed to new participants. FINDINGS: Between Nov 19, 2020, and April 14, 2023, 935 patients were randomly assigned. 335 (35·8%) of 935 patients were female and 600 (64·2%) were male. 465 (49·7%) of 935 were assigned to the standard protein group and 470 (50·3%) were assigned to the high protein group. 430 (92·5%) of 465 patients in the standard protein group and 419 (89·1%) of 470 patients in the high protein group were assessed for the primary outcome. The primary outcome, EQ-5D-5L health utility score during 180 days after randomisation (assessed at 30 days, 90 days, and 180 days), was lower in patients allocated to the high protein group than in those allocated to the standard protein group, with a mean difference of -0·05 (95% CI -0·10 to -0·01; p=0·031). Regarding safety outcomes, the probability of mortality during the entire follow-up was 0·38 (SE 0·02) in the standard protein group and 0·42 (0·02) in the high protein group (hazard ratio 1·14, 95% CI 0·92 to 1·40; p=0·22). There was a higher incidence of symptoms of gastrointestinal intolerance in patients in the high protein group (odds ratio 1·76, 95% CI 1·06 to 2·92; p=0·030). Incidence of other adverse events did not differ between groups. INTERPRETATION: High enteral protein provision compared with standard enteral protein provision resulted in worse health-related quality of life in critically ill patients and did not improve functional outcomes during 180 days after ICU admission. FUNDING: Netherlands Organisation for Healthcare Research and Development and Belgian Health Care Knowledge Centre.
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Estado Terminal , Proteínas Alimentares , Nutrição Enteral , Qualidade de Vida , Humanos , Masculino , Feminino , Estado Terminal/terapia , Bélgica , Método Duplo-Cego , Pessoa de Meia-Idade , Países Baixos , Nutrição Enteral/métodos , Idoso , Proteínas Alimentares/administração & dosagem , Recuperação de Função Fisiológica , Respiração Artificial , Unidades de Terapia IntensivaRESUMO
OBJECTIVE: Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). BACKGROUND: Evidence on SNM for idiopathic STC is conflicting and of suboptimal methodological quality. METHODS: The No.2-Trial was a multicenter, open-label, pragmatic, randomized trial performed in 2 Dutch hospitals. Sixty-seven patients with idiopathic STC, a defecation frequency <3 per week and refractory (ie, unresponsive) to maximal conservative (nonoperative) treatment were included. Exclusion criteria included outlet obstruction, rectal prolapse, and previous colon surgery. Patients were randomized (3:2) to SNM (n=41) or PCT (n=26) with randomization minimization between February 21, 2017 and March 12, 2020. In SNM patients, an implantable pulse generator was implanted after a successful 4-week test stimulation. PCT patients received conservative treatment such as laxatives or retrograde colonic irrigation. The primary outcome was treatment success (defined as average defecation frequency ≥3 per week) after 6 months. Secondary outcomes included constipation severity, fatigue, quality of life, and adverse events. Analysis was according to intention-to-treat. RESULTS: After 6 months, 22 (53.7%) patients were successfully treated with SNM versus 1 (3.8%) patient with PCT (odds ratio 36.4, 95% CI 3.4-387.5, P =0.003). At 6 months, SNM patients reported lower constipation severity and fatigue scores ( P <0.001) and improved quality of life compared with PCT ( P <0.001). Eight serious adverse events (6 SNM, 2 PCT) and 78 adverse events (68 SNM, 10 PCT) were reported. CONCLUSIONS: SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.
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Tratamento Conservador , Terapia por Estimulação Elétrica , Adulto , Adolescente , Humanos , Qualidade de Vida , Constipação Intestinal/terapia , Terapia por Estimulação Elétrica/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Trials have demonstrated the safety of omitting completion axillary lymph node dissection in patients with cT1-2 N0 breast cancer operated with breast-conserving surgery who have limited metastatic burden in the sentinel lymph node. The aim of this registry study was to provide insight into the oncological safety of omitting completion axillary treatment in patients operated with mastectomy who have limited-volume sentinel lymph node metastasis. METHODS: Women diagnosed in 2013-2014 with unilateral cT1-2 N0 breast cancer treated with mastectomy, with one to three sentinel lymph node metastases (pN1mi-pN1a), were identified from the Netherlands Cancer Registry, and classified by axillary treatment: no completion axillary treatment, completion axillary lymph node dissection, regional radiotherapy, or completion axillary lymph node dissection followed by regional radiotherapy. The primary endpoint was 5-year regional recurrence rate. Secondary endpoints included recurrence-free interval and overall survival, among others. RESULTS: In total, 1090 patients were included (no completion axillary treatment, 219 (20.1%); completion axillary lymph node dissection, 437 (40.1%); regional radiotherapy, 327 (30.0%); completion axillary lymph node dissection and regional radiotherapy, 107 (9.8%)). Patients in the group without completion axillary treatment had more favourable tumour characteristics and were older. The overall 5-year regional recurrence rate was 1.3%, and did not differ significantly between the groups. The recurrence-free interval was also comparable among groups. The group of patients who did not undergo completion axillary treatment had statistically significantly worse 5-year overall survival, owing to a higher percentage of non-cancer deaths. CONCLUSION: In this registry study of patients with cT1-2 N0 breast cancer treated with mastectomy, with low-volume sentinel lymph node metastasis, the 5-year regional recurrence rate was low and comparable between patients with and without completion axillary treatment.
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Neoplasias da Mama , Linfonodo Sentinela , Humanos , Feminino , Biópsia de Linfonodo Sentinela , Neoplasias da Mama/patologia , Mastectomia , Metástase Linfática/patologia , Excisão de Linfonodo , Linfonodo Sentinela/patologia , Mastectomia Segmentar , Axila/patologia , Sistema de Registros , Linfonodos/cirurgia , Linfonodos/patologiaRESUMO
BACKGROUND: Pregnancy is characterized by profound circulatory changes and compensatory adjustments in the renin-angiotensin-aldosterone system (RAAS). Differences in regulatory response may antedate or accompany vascular complicated pregnancy. We performed a systematic review and meta-analysis to delineate the trajectory of active plasma renin concentration (APRC) in healthy pregnancy and compare this to complicated pregnancy. METHODS: We performed a systematic review and meta-analysis on APRC during normotensive and hypertensive pregnancies, using PubMed (NCBI) and Embase (Ovid) databases. We included only studies reporting measurements during pregnancy together with a nonpregnant reference group measurement. Risk of bias was assessed with QUIPS. Ratio of the mean (ROM) and 95% confidence intervals (CI) of APRC values between pregnant and nonpregnant women were estimated for predefined intervals of gestational age using a random-effects model. Meta-regression was used to analyze APRC over time. RESULTS: In total, we included 18 studies. As compared to nonpregnant, APRC significantly increased as early as the first weeks of healthy pregnancy and stayed increased throughout the whole pregnancy (ROM 2.77; 95% CI 2.26-3.39). APRC in hypertensive complicated pregnancy was not significantly different from nonpregnancy (ROM 1.32; 95% CI 0.97-1.80). CONCLUSION: Healthy pregnancy is accompanied by a profound rise in APRC in the first trimester that is maintained until term. In hypertensive complicated pregnancy, this increase in APRC is not observed.
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Hipertensão , Complicações na Gravidez , Gravidez , Feminino , Humanos , Renina , Sistema Renina-Angiotensina , Pressão Sanguínea , AldosteronaRESUMO
BACKGROUND: The symptom of heavy menstrual bleeding has a substantial impact on professional, physical, and social functioning. In 2021, results from a randomized controlled trial comparing a 52-mg levonorgestrel-releasing intrauterine system and radiofrequency nonresectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during 2-year follow-up. However, long-term results are also relevant for both patients and healthcare providers. OBJECTIVE: This study aimed to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52-mg levonorgestrel-releasing intrauterine system or radiofrequency nonresectoscopic endometrial ablation. STUDY DESIGN: This study was a long-term follow-up study of a multicenter randomized controlled trial (MIRA trial), in which women were allocated to either a 52-mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency nonresectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out 6 questionnaires. The primary outcome was the reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function, and patient satisfaction. RESULTS: From the 270 women who were randomized in the original trial, 196 (52-mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency nonresectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range, 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52-mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency nonresectoscopic endometrial ablation group (relative risk, 1.39; 95% confidence interval, 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher among patients with a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system compared with radiofrequency nonresectoscopic endometrial ablation (35.3% [30/85] vs 19.1% [18/94]; relative risk, 1.84; 95% confidence interval, 1.11-3.10). However, the hysterectomy rate was similar (11.8% [10/94] in the 52-mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency nonresectoscopic endometrial ablation group; relative risk, 0.65; 95% confidence interval, 0.32-1.34). Most reinterventions occurred during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function, and patient satisfaction. CONCLUSION: The overall risk of reintervention after long-term follow-up was not different between women treated according to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system and those treated using a strategy starting with radiofrequency nonresectoscopic endometrial ablation. However, women allocated to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system had a higher risk of surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies were effective in lowering menstrual blood loss over the long term. The results of this long-term follow-up study can support physicians in optimizing the counseling of women with heavy menstrual bleeding, thus promoting informed decision-making regarding choice of treatment.
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Técnicas de Ablação Endometrial , Dispositivos Intrauterinos Medicados , Levanogestrel , Menorragia , Humanos , Feminino , Levanogestrel/administração & dosagem , Levanogestrel/uso terapêutico , Menorragia/cirurgia , Técnicas de Ablação Endometrial/métodos , Adulto , Seguimentos , Pessoa de Meia-Idade , Satisfação do Paciente , Qualidade de Vida , Reoperação/estatística & dados numéricos , Resultado do TratamentoRESUMO
BACKGROUND: Studies have shown that cancer survivors experience difficulties maintaining physical activity levels after participation in a supervised exercise rehabilitation program. This study aimed to assess the effectiveness of a six-month remote coaching intervention, following a supervised exercise oncology rehabilitation program on maintenance of PA levels; and improvement of aerobic capacity, muscle strength and patient-reported outcomes in cancer survivors. METHODS: Ninety-seven participants from a Dutch University Hospital's exercise rehabilitation program were randomised to the COACH group (n = 46), receiving 6 months of remote coaching after completing the exercise program, or the CONTROL group (n = 50), receiving no additional intervention. Assessment of PA levels; sedentary time; aerobic capacity; muscle strength; fatigue; health-related quality of life (HRQoL); level of anxiety and depression; and return to work (RTW) rates were conducted at baseline (T0) and six months later (T1). Multiple linear regression was used for between-group statistical comparisons of all outcomes measures. Mean differences at T1 were estimated with corresponding 95% confidence intervals (95%CI). RESULTS: No significant between-group differences were observed for all outcomes at T1. An adjusted mean difference in weekly PA of 45 min (95%CI -50;140) was observed between the COACH group and the CONTROL group, favouring the COACH group, yet lacking statistical or clinical significance. CONCLUSIONS: Our six-month remote coaching intervention did not notably improve PA levels; sedentary time; aerobic capacity; muscle strength; HRQoL; fatigue; anxiety and depression symptoms and RTW rates after participation in a supervised exercise oncology program. Although the participants who received coaching showed slightly higher levels of PA, these differences were not significant. More research is needed to identify patients in need for follow-up interventions following supervised exercise program and to investigate the effectiveness of remote coaching interventions in these patients. TRIAL REGISTRATION: Dutch Trial Register NL7729, registered 13 may 2019, https://trialsearch.who.int/Trial2.aspx?TrialID=NL7729 .
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Tutoria , Qualidade de Vida , Humanos , Terapia por Exercício , Aptidão Física , Exercício Físico , Fadiga/terapiaRESUMO
BACKGROUND: Although attempts have been made in the past to establish consensus regarding the definitions and grading of the severity of colorectal anastomotic leakage, widespread adoption has remained limited. OBJECTIVE: A systematic review of the literature was conducted with the objective of examining the various elements used to report and define anastomotic leakage in colorectal cancer resections. DATA SOURCES AND STUDY SELECTION: A systematic review, using the PubMed, Embase, and Cochrane Library Database, of all published randomized controlled trials, systematic reviews, and meta-analyses containing data related to adult patients undergoing colorectal cancer surgery and reporting anastomotic leakage as a primary or secondary outcome, with a definition of anastomotic leakage included. OUTCOMES: Definitions of anatomotic leakage, clinical symptoms, radiological modalities and findings, findings at reoperation, as well as grading terminology or classifications for anastomotic leakage. RESULTS: Of the 471 articles reporting anastomotic leakage as a primary or secondary outcome, a definition was reported in 95 studies (45 randomized controlled trials, 13 systematic reviews, and 37 meta-analyses), involving a total of 346,140 patients. Of these 95 articles, 68% reported clinical signs and symptoms of anastomotic leakage, 26% biochemical criteria, 63% radiological modalities, 62% radiological findings, and 13% findings at reintervention. Only 45% (n = 43) of included studies reported grading of anastomotic leakage severity or leak classification, and 41% (n = 39) included a timeframe for reporting. LIMITATIONS: There was a high heterogeneity between the included studies. CONCLUSION: This evidence synthesis confirmed incomplete and inconsistent reporting of anastomotic leakage across the published colorectal cancer literature. There is a great need for the development and implementation of a consensus framework for defining, grading, and reporting anastomotic leakage. REGISTRATION: Prospectively registered at PROSPERO ID 454660.
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INTRODUCTION: Flap fixation after mastectomy has proven to be one of the most promising solutions to reduce seroma formation. Drain placement remains standard practice in many clinics, even though this may be redundant after flap fixation. METHODS: This is a prospective randomized controlled trial comparing mastectomy and wound closure using flap fixation with or without drain placement. The primary outcome measure was clinically significant seroma (CSS) incidence. The aim of this interim analysis was to assess the assumptions for the sample size calculation and to provide preliminary results. RESULTS: Between July 2020 and January 2023, 112 patients were included. CSS incidence was 9.1% in the drain group and 21% in the no-drain group. In total, 10 patients were lost to follow-up. These numbers are similar to the ones used for the sample size calculation. In the drain group, three patients required interventions for wound complications compared to nine in the no-drain group (odds ratio: 3.612 [95% confidence interval: 0.898-14.537]). CONCLUSION: The sample size calculation seems to be correct and no protocol amendments are necessary. Current preliminary results show no significant differences in CSS incidence. Complete results should be awaited to draw a well-powered conclusion regarding drain policy after mastectomy.
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Neoplasias da Mama , Mastectomia , Humanos , Feminino , Mastectomia/efeitos adversos , Seroma/etiologia , Seroma/prevenção & controle , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicações , Drenagem/efeitos adversosRESUMO
Flap fixation is the most promising solution to prevent seroma formation after mastectomy. In this systematic review with network meta-analysis (NMA), three different techniques were compared. The NMA included 25 articles, comprising 3423 patients, and revealed that sutures are superior to tissue glue in preventing clinically significant seroma. In addition, running sutures seemed to be superior to interrupted sutures. An RCT comparing these suture techniques seems necessary, given the quality and nature of existing literature.
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Neoplasias da Mama , Mastectomia , Seroma , Técnicas de Sutura , Feminino , Humanos , Neoplasias da Mama/cirurgia , Mastectomia/efeitos adversos , Mastectomia/métodos , Metanálise em Rede , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Seroma/etiologia , Seroma/prevenção & controle , Retalhos CirúrgicosRESUMO
OBJECTIVE: To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy. DESIGN: Multicentre non-inferiority randomised controlled trial. SETTING: Five teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. METHODS: Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD). MAIN OUTCOME MEASURES: The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L). RESULTS: Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. CONCLUSION: This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.
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INTRODUCTION AND HYPOTHESIS: Patient-reported outcomes are relevant outcomes in studies on pelvic organ prolapse (POP) surgery, as anatomical recurrence alone does not have a significant correlation with perceived improvement. In the present study, the patient's impression of improvement after 1 year is studied after vaginal hysterectomy (VH) versus sacrospinous hysteropexy (SSH) in large cohorts from daily clinical practice. We hypothesize that there is no difference between the groups. METHODS: This is a secondary analysis on prospectively collected data in a multicenter cohort of patients who underwent VH or SSH for symptomatic POP. All patients had a POP-Q stage ≥ 2 in at least one compartment at baseline and were treated with VH or SSH between 2002 and 2019. The primary outcome was the patient-reported score on the patient global impression of improvement index (PGI-I) 1 year after surgery. The secondary outcome was a composite outcome of surgical success, defined as the absence of recurrent POP beyond the hymen with bothersome bulge symptoms and/or repeat surgery. RESULTS: A total of 378 women (196 VH and 182 SSH) were included. The median score on the PGI-I did not differ between VH and SSH. At 1 year post-operatively, 77 women after VH (73%) and 77 women after SSH (75%) considered their condition (very) much improved (p = 0.86). There was no difference in composite outcome of surgical success (126 out of 137 women [92%] after VH, 118 out of 125 women [94%] after SSH; p = 0.44). CONCLUSIONS: Our study shows that there was no difference in the type of surgery, VH or SSH, with regard to the patient's impression of improvement 1 year postoperatively in a large cohort from daily clinical practice.
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Histerectomia Vaginal , Medidas de Resultados Relatados pelo Paciente , Prolapso de Órgão Pélvico , Humanos , Feminino , Histerectomia Vaginal/métodos , Prolapso de Órgão Pélvico/cirurgia , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Estudos Prospectivos , Procedimentos Cirúrgicos em Ginecologia/métodos , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Posttraumatic wrist osteoarthritis is an irreversible and often progressive condition. Many surgical treatments, used in (daily) practice, aim to relieve symptoms like pain and restore function. The aim of this systematic review is to assess the patient reported and functional outcomes of the most common surgical interventions in patients with posttraumatic wrist osteoarthritis. This overview can help clinicians select the best treatment and manage patient's expectations. METHODS: A literature search was performed in Pubmed, Embase and Cochrane for articles published between 1990 and November 2022 according to the PRISMA guidelines. The study protocol has been registered in the PROSPERO database (CRD42017080427). Studies that describe patient reported outcomes (pain and Disability of Arm, Shoulder and Hand (DASH) -score) and functional outcomes (range of motion (ROM) and grip strength) after surgical intervention with a minimal follow-up of 1 year were included. The identified surgical procedures included denervation, proximal row carpectomy, interpositional- and total arthroplasty, and midcarpal-, radiocarpal- and total arthrodesis. The pre-and postoperative outcomes were pooled and presented per salvage procedure. RESULTS: Data from 50 studies was included. Pain score improved after all surgeries except denervation. Flexion/extension decreased after radiocarpal arthrodesis, did not show significant changes after proximal row carpectomy, and improved for all other surgeries. DASH score improved after arthroplasty, proximal row carpectomy and midcarpal arthrodesis. Grip strength improved after interposition arthroplasty and partial arthrodesis. CONCLUSION: Evidence from this review did not support the indication for denervation in this particular patient population. In patients with SLAC/SNAC II, proximal row carpectomy might be favourable to a midcarpal arthrodesis solely based on better FE ROM of the radiocarpal joint after proximal row carpectomy. In terms of radiocarpal mobility, total wrist arthroplasty might be preferred to radiocarpal arthrodesis in patients with osteoarthritis after a distal radius fracture. More uniform measurements of outcomes would improve the understanding of the effect of surgical treatments of the posttraumatic osteoarthritic wrist.
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Osteoartrite , Medidas de Resultados Relatados pelo Paciente , Amplitude de Movimento Articular , Terapia de Salvação , Articulação do Punho , Humanos , Osteoartrite/cirurgia , Articulação do Punho/cirurgia , Articulação do Punho/fisiopatologia , Terapia de Salvação/métodos , Artrodese/métodos , Força da Mão , Resultado do Tratamento , Traumatismos do Punho/cirurgia , Traumatismos do Punho/fisiopatologia , Recuperação de Função Fisiológica , Denervação/métodosRESUMO
BACKGROUND AND AIMS: The current study proposes a novel volume-outcome (V-O) meta-analytical approach to determine the optimal annual hospital case volume threshold for cardiovascular interventions in need of centralization. This novel method is applied to surgery for acute type A aortic dissection (ATAAD) as an illustrative example. METHODS: A systematic search was applied to three electronic databases (1 January 2012 to 29 March 2023). The primary outcome was early mortality in relation to annual hospital case volume. Data were presented by volume quartiles (Qs). Restricted cubic splines were used to demonstrate the V-O relation, and the elbow method was applied to determine the optimal case volume. For clinical interpretation, numbers needed to treat (NNTs) were calculated. RESULTS: One hundred and forty studies were included, comprising 38 276 patients. A significant non-linear V-O effect was observed (P < .001), with a notable between-quartile difference in early mortality rate [10.3% (Q4) vs. 16.2% (Q1)]. The optimal annual case volume was determined at 38 cases/year [95% confidence interval (CI) 37-40 cases/year, NNT to save a life in a centre with the optimal volume vs. 10 cases/year = 21]. More pronounced between-quartile survival differences were observed for long-term survival [10-year survival (Q4) 69% vs. (Q1) 51%, P < .01, adjusted hazard ratio 0.83, 95% CI 0.75-0.91 per quartile, NNT to save a life in a high-volume (Q4) vs. low-volume centre (Q1) = 6]. CONCLUSIONS: Using this novel approach, the optimal hospital case volume threshold was statistically determined. Centralization of ATAAD care to high-volume centres may lead to improved outcomes. This method can be applied to various other cardiovascular procedures requiring centralization.
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Dissecção Aórtica , Hospitais com Alto Volume de Atendimentos , Humanos , Resultado do Tratamento , Dissecção Aórtica/cirurgia , Estudos RetrospectivosRESUMO
INTRODUCTION: Cutaneous vascular reactivity to local heating in free flaps has not been characterized. We aimed to assess local heating-induced cutaneous vasodilation in reinnervated and noninnervated deep inferior epigastric perforator (DIEP) flaps. METHODS: We conducted a cross-sectional study of 21 female patients with an uncomplicated unilateral delayed DIEP breast reconstruction at least 2 years after surgery. DIEP flaps and contralateral breasts were subjected to direct local heating, and skin blood flow was assessed using laser-Doppler flowmetry. To evaluate sensory-nerve-fiber function, touch perception thresholds were assessed using a 20-piece Touch-test™ Sensory Evaluator, and cutaneous warm detection and heat pain thresholds were measured using a TSA-II device. RESULTS: Of the participants, 10 had a reinnervated DIEP flap with a single coapted nerve (mean flap weight, 610 ± 296 g) and 11 had a noninnervated DIEP flap (mean flap weight, 613 ± 169 g). Mean age was 58 ± 11 years, mean follow-up time was 5 ± 1 years, and mean BMI was 24 ± 3 kg/m2 . DIEP flaps exhibited significantly weaker cutaneous vasodilation in response to local heating than contralateral breasts (median peak skin blood flow, 59 [25th-75th percentile, 36-71] a.u. for DIEP flaps versus 94 [74-141] a.u. for contralateral breasts; p < .001). The magnitude of the response was similar between reinnervated and noninnervated flaps (median peak skin blood flow, 55 [25th-75th percentile, 39-68] a.u. for reinnervated DIEP flaps versus 66 [36-77] a.u. for noninnervated DIEP flaps; p = .75). Of participants with reinnervated DIEP flaps, 90% perceived heat pain below the 50°C safety threshold, as compared to 36% of participants with noninnervated DIEP flaps (two-tailed p = .02). CONCLUSION: Our results suggest that free flap transfer causes longstanding impairment, yet not complete abolition, of both the sensory nerve-mediated and nitric oxide-dependent local heating-induced cutaneous vasodilatory systems. We found no statistical evidence that flap reinnervation improves the ability to raise skin blood flow in response to local heating.
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Mamoplastia , Retalho Perfurante , Feminino , Humanos , Pessoa de Meia-Idade , Idoso , Retalho Perfurante/irrigação sanguínea , Vasodilatação , Estudos Transversais , Calefação , Mama , Mamoplastia/métodos , Artérias Epigástricas , Estudos RetrospectivosRESUMO
INTRODUCTION: With increasing incidence of facial skin cancer, more patients undergo facial reconstruction following Mohs micrographic surgery (MMS). Aesthetically unpleasing, thickened facial flaps, and disturbing scars can be treated with a pressure mask with inner silicone lining to help improve functional and aesthetic outcomes. However, data on long-term patient satisfaction and quality of life (QoL) following this treatment are lacking. METHODS: We aimed to assess long-term satisfaction and QoL of patients who underwent local flap reconstruction following MMS. Patients treated between January 2012 and October 2020 were invited to answer FACE-Q and SCAR-Q questionnaires. Demographic data, skin cancer type and location, type of reconstruction, postoperative complications, duration of pressure mask therapy, daily compliance, and additional scar treatment were collected to explore possible predictors. RESULTS: Of 92 eligible patients, 50 responded. Eighteen respondents were male (36%) and 32 were female (64%). Mean duration of pressure mask therapy was 10.20 ± 4.61 months. Patients were 61.14 ± 32.91 months after completion of pressure mask therapy upon participation. Patients whose reconstruction consisted of multiple flaps had significantly worse outcomes in social function (p = 0.012), scar appearance (p = 0.045), and scar symptoms (p = 0.008). A trend of increasing time since therapy completion predicting better outcomes was observed for all scales, and it was a significant predictor for better scar appearance (p = 0.001) and less scar symptoms (p = 0.001). CONCLUSION: Pressure mask treatment for facial flaps and scars following MMS results in good long-term patient satisfaction and QoL. Multiple local flaps, reflecting a larger skin defect postexcision, is a predictor for worse outcomes in social function, scar appearance, and symptoms. Increasing time is associated with increasing satisfaction, which reflects satisfactory and stable long-term effects of treatment, possibly combined with more acceptance of the result over time.
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Cicatriz , Neoplasias Cutâneas , Humanos , Masculino , Feminino , Cicatriz/etiologia , Cicatriz/cirurgia , Qualidade de Vida , Satisfação do Paciente , Máscaras/efeitos adversos , Estética Dentária , Neoplasias Cutâneas/cirurgiaRESUMO
OBJECTIVES: Intravenous thrombolysis (IVT) is recommended in patients with ischemic stroke in the anterior and posterior circulation. Neurological outcomes due to posterior circulation strokes (PCS) without treatment remain poor. Our aim was to overview the literature on outcomes of IVT and conservative treatment in PCS, based on a systematic review and meta-analysis. METHODS: A systematic literature search was performed on February 27th 2023. Outcome measures included favorable functional outcome at 90 days (modified Rankin Scale [mRS] 0-2), mortality at 90 days, and symptomatic intracranial hemorrhages (sICH). Weighted averages with DerSimonian-Laird approach was used to analyze the data. Subgroup analyses by time window were performed: standard time window (<4.5 hours after symptom onset) and extended time window (>4.5 hours). Analyses were performed using R. RESULTS: Eight prospective and four retrospective cohort studies were included (n = 1589 patients); no studies with conservative treatment were eligible. The pooled weighted probability regarding favorable functional outcome after IVT was 63 % (95 %CI:0.45-0.78), for mortality 19 % (95 %CI:0.11-0.30), and for sICH 4 % (95 %CI:0.02-0.07). Subgroup analyses showed higher probabilities on achieving favorable functional outcomes for patients treated in the standard (77 %; 95 %CI:0.62-0.88) compared to the extended time window (38 %; 95 %CI:0.29-0.48) with RR = 1.93 (95 %CI:1.66-2.24). Lower probabilities regarding mortality at 90 days and sICH were seen in patients treated in standard compared to extended time window (RR = 0.42, 95 %CI:0.34-0.51 and RR = 0.27, 95 %CI:0.16-0.45, respectively). CONCLUSIONS: IVT in patients with PCS seems to be safe and effective in standard and extended time window. The effect of IVT is higher in the standard time window.
Assuntos
Fibrinolíticos , AVC Isquêmico , Recuperação de Função Fisiológica , Terapia Trombolítica , Tempo para o Tratamento , Humanos , Terapia Trombolítica/efeitos adversos , Terapia Trombolítica/mortalidade , Fibrinolíticos/administração & dosagem , Fibrinolíticos/efeitos adversos , AVC Isquêmico/tratamento farmacológico , AVC Isquêmico/mortalidade , AVC Isquêmico/diagnóstico , AVC Isquêmico/fisiopatologia , Resultado do Tratamento , Fatores de Tempo , Fatores de Risco , Idoso , Feminino , Masculino , Pessoa de Meia-Idade , Avaliação da Deficiência , Estado Funcional , Infusões Intravenosas , Idoso de 80 Anos ou mais , Administração Intravenosa , Medição de Risco , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/mortalidadeRESUMO
BACKGROUND: A better insight in how the biopsychosocial factors influence patient outcome(s) may provide information that helps selecting the optimal pain management for a specific group. METHODS: Categorization was made in the prospective DATAPAIN registry, in which patients with pain severity (Numeric Rating Scale [NRS]: 7-10), depression or anxiety (Hospital Anxiety and Depression Scale: > 10), and pain catastrophizing (Pain Catastrophizing Scale: > 31) were identified as complex cases. Patient outcomes; treatment satisfaction on the Patient Global Impression of Change (PGIC), pain relief (NRS), pain interference on the Brief Pain Inventory (BPI) and quality of life indicator General Perceived Health (GPH) were evaluated. Logistic regression analyzed if belonging to the complex cases showed modification in the outcome of the PGIC and GPH. Linear regression was observed if complex cases differed in average reduction in pain relief and interference compared to non-complex cases. RESULTS: 1637 patients were included, of which 345 (21.08%) were considered complex cases. The changes in scores of pain relief and BPI active subscale were not significantly different between groups. The BPI affective subscale had a different change in score (-0.509; p: 0.002). The complex cases had an odds ratio (OR) of 0.59 (95% confidence interval [CI]: 0.36-0.77) on treatment satisfaction compared to non-complex cases, and an OR of 0.28 (95% CI: 0.11-0.56) on the GPH. CONCLUSION: When treating patients with complex cases, desired treatment outcome(s) should be recognized by specialists and patients, as these may be less likely to occur.
Assuntos
Dor Crônica , Humanos , Dor Crônica/terapia , Estudos Prospectivos , Qualidade de Vida , Motivação , Resultado do TratamentoRESUMO
OBJECTIVES: Previous studies have identified the added value of flap fixation in reducing seroma formation and its sequelae after mastectomy. The seroma reduction after mastectomy (SAM)-trial proved that sutures were superior to tissue glue. In this article, we will elaborate on the results of the SAM-trial to provide a clear surgical guideline. METHODS: All patients in the suture flap fixation cohort from the SAM-trial were analyzed if details regarding flap fixation were available. The most optimal number of sutures was determined using a receiving operator characteristics curve. The incidence of seroma formation between patients receiving the most optimal number of sutures and patients receiving fewer sutures was compared. RESULTS: The most optimal number of sutures proved to be 15. Patients with ≥15 sutures had a lower incidence of seroma formation at every time frame during follow-up. There was a significant difference at 6 weeks (odds ratio [OR]: 3.05, 95% confidence interval [CI]: 1.09-8.56), 3 months (OR: 4.62, 95% CI: 1.34-12.92), and 1 year postoperatively (OR: 20.48, 95% CI: 2.18-192.22). Ten days and 6 months postoperatively did not differ significantly. CONCLUSIONS: Flap fixation in general, but also the surgical technique influences the incidence of seroma formation after mastectomy. Results suggest a minimum of 15 sutures, spaced approximately 3.7 cm apart.
Assuntos
Neoplasias da Mama , Mastectomia , Humanos , Feminino , Mastectomia/efeitos adversos , Mastectomia/métodos , Seroma/etiologia , Seroma/prevenção & controle , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicações , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/epidemiologia , Retalhos Cirúrgicos/cirurgia , Drenagem/efeitos adversos , Técnicas de Sutura/efeitos adversosRESUMO
BACKGROUND: The status of regional tumour draining lymph nodes (LN) is crucial for prognostic evaluation in gastric cancer (GaC) patients. Changes in lymph node microarchitecture, such as follicular hyperplasia (FH), sinus histiocytosis (SH), or paracortical hyperplasia (PH), may be triggered by the anti-tumour immune response. However, the prognostic value of these changes in GaC patients is unclear. METHODS: A systematic search in multiple databases was conducted to identify studies on the prognostic value of microarchitecture changes in regional tumour-negative and tumour-positive LNs measured on histopathological slides. Since the number of GaC publications was very limited, the search was subsequently expanded to include junctional and oesophageal cancer (OeC). RESULTS: A total of 28 articles (17 gastric cancer, 11 oesophageal cancer) met the inclusion criteria, analyzing 26,503 lymph nodes from 3711 GaC and 1912 OeC patients. The studies described eight different types of lymph node microarchitecture changes, categorized into three patterns: hyperplasia (SH, FH, PH), cell-specific infiltration (dendritic cells, T cells, neutrophils, macrophages), and differential gene expression. Meta-analysis of five GaC studies showed a positive association between SH in tumour-negative lymph nodes and better 5-year overall survival. Pooled risk ratios for all LNs showed increased 5-year overall survival for the presence of SH and PH. CONCLUSIONS: This systematic review suggests that sinus histiocytosis and paracortical hyperplasia in regional tumour-negative lymph nodes may provide additional prognostic information for gastric and oesophageal cancer patients. Further studies are needed to better understand the lymph node reaction patterns and explore their impact of chemotherapy treatment and immunotherapy efficacy.
Assuntos
Neoplasias Esofágicas , Histiocitose Sinusal , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirurgia , Neoplasias Gástricas/patologia , Hiperplasia/patologia , Histiocitose Sinusal/patologia , Relevância Clínica , Linfonodos/cirurgia , Linfonodos/patologia , Prognóstico , Neoplasias Esofágicas/patologia , Estadiamento de NeoplasiasRESUMO
OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.