title: PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial.
abstract: BACKGROUND
  Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications.
  
  
  METHODS
  One hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement.
  
  
  CONCLUSIONS
  The PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh.
  
  
  BACKGROUND
  The PREVENT-trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018.
authors.affiliation: Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands. henkthijs@hotmail.com
authors.forename: Henk-Thijs
authors.initials: HT
authors.lastname: Brandsma
authors.forename: Birgitta M E
authors.initials: BM
authors.lastname: Hansson
authors.forename: Hilde
authors.initials: H
authors.lastname: V-Haaren-de Haan
authors.forename: Theo J
authors.initials: TJ
authors.lastname: Aufenacker
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
authors.forename: Rob P
authors.initials: RP
authors.lastname: Bleichrodt
mesh_terms: D002985:Clinical Protocols; D003125:Colostomy / Q000009:adverse effects*; D006555:Hernia, Ventral / Q000517:prevention & control*; D006801:Humans; D011183:Postoperative Complications / Q000517:prevention & control*; D016037:Single-Blind Method; D013526:Surgical Mesh; D054047:Surgical Stomas