Dataset Information

Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5-8-year follow-up of the ROCSS randomized controlled trial.

ABSTRACT:

Background

The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5-8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall-specific quality of life score.

Methods

Eligible participants from original UK centres were identified. The primary outcome (abdominal wall-specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients' original allocation, even if the patient was aware of their treatment.

Results

Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (-2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04).

Conclusions

ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall-specific quality of life 5-8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on.

Trial registration

ISRCTN25584182 (http://www.clinicaltrials.gov).

SUBMITTER: Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and West Midlands Research Collaborative

PROVIDER: S-EPMC11317774 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5-8-year follow-up of the ROCSS randomized controlled trial.

The British journal of surgery 20240801 8

<h4>Background</h4>The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5-8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall-specific quality of life score.<h4>Methods</h4>Eligible participants from original UK centres were identified. The primary outcome (abdominal wall-specific quality of ...[more]

PMID: 39129618

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Project description:BackgroundClosure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site.MethodsIn this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964.FindingsBetween Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43-0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26-0·69; p<0·001). There was also a reduction in symptomatic hernia (16%, 52 of 329 vs 19%, 64 of 331; adjusted relative risk 0·83, 0·60-1·16; p=0·29) and surgical reintervention (12%, 42 of 344 vs 16%, 54 of 346: adjusted relative risk 0·78, 0·54-1·13; p=0·19) at 2 years, but this result did not reach statistical significance. No significant differences were seen in wound infection rate, seroma rate, quality of life, pain scores, or serious adverse events.InterpretationReinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias.FundingNational Institute for Health Research Research for Patient Benefit and Allergan.

Project description:IntroductionWomen are related to higher stroke risk and poorer outcome after stroke attack in patients with non-valvular atrial fibrillation (NVAF). The sex differences in efficacy and safety after left atrial appendage closure (LAAC) have remained elusive. This retrospective study aimed to investigate the safety, feasibility, and clinical outcomes of LAAC between women and men.MethodsFrom 2014 to 2018, 395 patients who underwent LAAC in our center were enrolled in this retrospective study. Baseline clinical characteristics, procedural parameters, and postoperative follow-up data were collected and compared between women and men.ResultsThe study included 154 women and 241 men. Compared with men, women were older (68.1 ± 7.9 vs. 64.6 ± 8.8, p < 0.01**), with higher CHA2DS2-VASc score (4.0 ± 1.7 vs. 3.0 ± 1.6, p < 0.01**). During the mean follow-up duration of 1,566 days (4.3 years), there were 39 major adverse cardiovascular events (MACE, including 19 cardiovascular or unexplained deaths, 15 ischemic strokes, and 5 major bleedings) recorded in 34 patients. The overall rate of ischemic stroke was 0.9 per 100 patient-years, and the overall rate of MACE was 2.1 per 100 patient-years. The cardiovascular or unexplained death and major bleeding were comparable between women and men. Compared with men, women had lower rates of ischemic stroke, fatal or disabling ischemic stroke, MACE, and fatal or disabling MACE, but none of them reached statistical differences (HR: 0.361, p = 0.099, HR: 0.429, p = 0.276, HR: 0.600, p = 0.170, and HR: 0.621, p = 0.254, respectively). In the adjusted analyses with multivariate Cox regression models, women had a lower fatal or disabling ischemic stroke rate compared with men (HR: 0.100, p = 0.041).ConclusionLeft atrial appendage closure was feasible and safe for patients of both genders. The ischemic stroke, cardiovascular or unexplained death, and major bleeding were comparable between women and men. However, women were the independent protective factors against fatal or disabling ischemic stroke after LAAC implantation.

Dataset Information

Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5-8-year follow-up of the ROCSS randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5-8-year follow-up of the ROCSS randomized controlled trial.

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