title: Prophylactic mesh to prevent parastomal hernia after end colostomy: a meta-analysis and trial sequential analysis.
abstract: Prevention of parastomal hernia (PSH) formation is crucial, given the high prevalence and difficulties in the surgical repair of PSH. To investigate the effect of a preventive mesh in PSH formation after an end colostomy, we aimed to meta-analyze all relevant randomized controlled trials (RCTs).
  
  
  
  We searched five databases. For each trial, we extracted risk ratios (RRs) of the effects of mesh or no mesh. The primary outcome was incidence of PSH with a minimum follow-up of 12 months with a clinical and/or computed tomography diagnosis. RRs were combined using the random-effect model (Mantel-Haenszel). To control the risk of type I error, we performed a trial sequential analysis (TSA).
  
  
  
  Seven RCTs with low risk of bias (451 patients) were included. Meta-analysis for primary outcome showed a significant reduction of the incidence of PSH using a mesh (RR 0.43, 95% CI 0.26-0.71; P = 0.0009). Regarding TSA calculation for the primary outcome, the accrued information size (451) was 187.1% of the estimated required information size (RIS) (241). Wound infection showed no statistical differences between groups (RR 0.77, 95% CI 0.39-1.54; P = 0.46). PSH repair rate showed a significant reduction in the mesh group (RR 0.28 (95% CI 0.10-0.78; P = 0.01).
  
  
  
  PSH prevention with mesh when creating an end colostomy reduces the incidence of PSH, the risk for subsequent PSH repair and does not increase wound infections. TSA shows that the RIS is reached for the primary outcome. Additional RCTs in the previous context are not needed.
authors.affiliation: Abdominal Wall Surgery Unit, Department of General Surgery, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain. mlpezcano@gmail.com.
authors.forename: M
authors.identifier: 0000-0003-3337-0756
authors.initials: M
authors.lastname: López-Cano
authors.affiliation: Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
authors.forename: H-T
authors.initials: HT
authors.lastname: Brandsma
authors.affiliation: Department Cardiac and Vascular Surgery, Medical University of Gdansk, Gdańsk, Poland.
authors.forename: K
authors.initials: K
authors.lastname: Bury
authors.affiliation: Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: Hansson
authors.affiliation: Department of Surgery, Maria Middelares Hospital, Ghent, Belgium.
authors.forename: I
authors.initials: I
authors.lastname: Kyle-Leinhase
authors.affiliation: Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
authors.forename: J G
authors.initials: JG
authors.lastname: Alamino
authors.affiliation: Department of Surgery, Maria Middelares Hospital, Ghent, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Muysoms
mesh_terms: D003125:Colostomy / Q000009:adverse effects* / Q000379:methods; D006555:Hernia, Ventral / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D013526:Surgical Mesh
keywords: Hernia; Mesh; Parastomal; Prevention; Prophylaxis