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

Trials

Rob P Bleichrodt²  Camiel Rosman²  Theo J Aufenacker¹  Hilde V-Haaren-de Haan²  Birgitta ME Hansson²  Henk-Thijs Brandsma² 

[1] Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands;Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands

关键词: Colostomy;    Mesh;    Prevention;    Prophylactic;    Parastomal hernia;   

Others  :  1095124
DOI  :  10.1186/1745-6215-13-226

 received in 2012-06-17, accepted in 2012-11-02,  发布年份 2012

【 摘 要 】

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.

Discussion

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.

Trial registration

The PREVENT-trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018 webcite

【 授权许可】

   
2012 Brandsma et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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