Evidence map›Paper›PMID 39129618›Full record

Trial reportThe British journal of surgery2024

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.

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

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The British journal of surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

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

Funding

National Institute for Health Research NIHR202011
6 · The paper itself

Abstract

backgroundThe 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.

methodsEligible 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.

resultsOf 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).

conclusionsROCSS-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 registrationISRCTN25584182 (http://www.clinicaltrials.gov).

Indexed as

Cost-Benefit AnalysisIncisional HerniaQuality of LifeSurgical MeshSurgical StomasAgedFemaleFollow-Up StudiesHumansMaleMiddle Aged

Identifiers

PMID39129618
PMCPMC11317774

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.