Reoperation rate for recurrence 41 months after primary umbilical/epigastric or incisional hernia repair underestimated overall risk of recurrence by four- to fivefolds. This study was registered in www.clinicaltrials.gov (NCT01325246).
Background Closure 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. Methods In 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.
Background and Aims: The use of mesh repair in a small- or middle-sized umbilical hernia remains controversial, and evidence is based on only few and small heterogeneous randomized trials. The primary aim was to assess differences, if any, in recurrence (clinical and reoperation), and secondary aim was to assess differences in infections, seroma formation, hematomas, chronic pain, cosmetic result, and quality of life. Method: A systematic review (predefined search strategy) and meta-analyses were conducted based on pre-study strict and well-defined methodology. The literature search was completed on 1 January 2018. The study protocol was registered in PROSPERO. Results: Five randomized controlled trials were identified (mesh repair, n = 326 versus non-mesh sutured repair, n = 330) and 602 records were excluded. Randomized controlled trials included patients with defect diameters of ⩾1 to 4 cm. Mesh repair reduced the risk of recurrence compared with sutured repair with a relative risk of 0.28 (95% confidence interval = 0.13–0.58, I2 = 0%, number needed to treat = 13 patients). Additional analyses found no differences between the two surgical techniques regarding infection (relative risk = 0.80, 95% confidence interval = 0.36–1.79), seroma formation (relative risk = 1.38, 95% confidence interval = 0.57–3.32), or hematomas (relative risk = 0.55, 95% confidence interval = 0.23–1.30). Lack of sufficient data precluded meta-analysis evaluating risk of seroma formation, hematomas, chronic pain, cosmetic result, and quality of life. Conclusion: Mesh repair is recommended for umbilical hernia of ⩾1 to 4 cm. More evidence is needed for the optimal placement of the mesh (sublay or onlay) and the role of mesh in patients with an umbilical hernia <1 cm.
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