Dataset Information

Prevention of incisional hernia at the site of stoma closure with different reinforcing mesh types: a systematic review and meta-analysis.

ABSTRACT:

Purpose

To evaluate safety and efficacy of a mesh reinforcement following stoma reversal to prevent stoma site incisional hernia (SSIH) and differences across the prostheses used.

Methods

A systematic search of PubMed/MEDLINE, EMBASE, SCOPUS and Cochrane databases was conducted to identify comparative studies until September 2020. A meta-analysis of postoperative outcomes and a network meta-analysis for a multiple comparison of the prostheses with each other were performed.

Results

Seven studies were included in the analysis (78.4% ileostomy and 21.6% colostomy) with a total of 1716 patients with (n = 684) or without (n = 1032) mesh. Mesh placement was associated with lower risk of SSIH (7.8%vs18.1%, OR0.266,95% CI 0.123-0.577, p < 0.001) than no mesh procedures but also with a longer operative time (SMD 0.941, 95% CI 0.462-1.421, p < 0.001). There was no statistically significant difference in terms of Surgical Site infection (11.5% vs 11.1%, OR 1.074, 95% CI 0.78-1.48, p = 0.66), seroma formation (4.4% vs 7.1%, OR 1.052, 95% CI 0.64-1.73, p = 0.84), anastomotic leakage (3.7% vs 2.7%, OR 1.598, 95% CI 0.846-3.019, p = 0.149) and length of stay (SMD - 0.579,95% CI - 1.261 to 0.102, p = 0.096) between mesh and no mesh groups. Use of prosthesis was associated with a significant lower need for a reoperation than no mesh group (8.1% vs 12.1%, OR 0.332, 95% CI 0.119-0.930, p = 0.036). Incidence of seroma is lower with biologic than polypropylene meshes but they showed a trend towards poor results compared with polypropylene or biosynthetic meshes.

Conclusion

Despite longer operative time, mesh prophylactic reinforcement at the site of stoma seems a safe and effective procedure with lower incidence of SSIH, need for reoperation and comparable short-term outcomes than standard closure technique. A significant superiority of a specific mesh type was not identified.

SUBMITTER: Peltrini R

PROVIDER: S-EPMC8197707 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:IntroductionIncisional hernia (IH) is a common complication of abdominal surgery affecting between 10% and 20% of patients and is associated with significant morbidity along with cost to the National Health Service. With high recurrence rates following repair, focus must be on prevention of IH rather than cure. There is an increasing evidence that patients at high risk of developing IH may benefit from prophylactic mesh placement during their index operation. With recent controversy surrounding the use of mesh in the UK, however, there is little understanding of whether this intervention would be acceptable to patients.Methods and analysisINVITE is a mixed-methods, cross-sectional study to explore patient perceptions of the use of mesh as prophylaxis to prevent IH. Patients with and without IH who have undergone colorectal surgery between 2017 and 2020 in a single UK health-board will be approached to participate. 120 participants will be asked to complete a questionnaire and a subgroup of 24 participants will be invited to semistructured interviews. The primary outcome is to assess the acceptability of prophylactic mesh to patients. Secondary outcomes include understanding patients' knowledge of IH, and factors that may influence or alter the acceptability of mesh. Questionnaires have been developed using a 5-point Likert scale to allow quantitative analysis. Qualitative analysis of interviews will be conducted using NVivo software and thematic analysis. Data will be presented using the Journal Article Reporting Standards for mixed-methods research.Ethics and disseminationEthical approval has been granted by REC Wales (22/PR/0678), and the study is currently in setup. All participants will be required to provide informed consent prior to their participation in the study. We plan to report the results of the study in peer-reviewed scientific and medical journals and via presentations at scientific meetings. Results from this study will aid the design of interventional trials using prophylactic mesh.Trial registration numberNCT05384600.