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

BackgroundParastomal 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.MethodsOne 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.DiscussionThe 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 registrationThe PREVENT-trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018

Systematic Review and Meta-analysis of Prophylactic Mesh During Primary Stoma Formation to Prevent Parastomal Hernia

“…A number of trials were identified from online registers, with a combined population exceeding 1,600 patients. One of these, the PREVENT study (NTR2018; trialsregister.nl) 19 , is expected to publish outcomes in the next 12 months, with interim outcomes already reported 20 . Strengths of this study compared to current literature include a larger study population and patient blinding, In addition, it has been suggested that mesh-related comorbidity such as contamination may be reduced by intraperitoneal placement of mesh, however others have raised concerns over the risk of intestinal obstruction related to this approach 4,21 .…”

Parastomal Hernia: A Growing Problem with New Solutions

“…A recent cost-effectiveness analysis also demonstrated cost savings and improvement in effectiveness for patients with Stage I to III rectal cancer undergoing APR with prophylactic mesh placement [106]. While most studies to date have had small sample sizes at single institutions, larger multi-center, randomized, controlled trials are currently underway, which may provide stronger evidence to support prophylactic mesh placement at the time of permanent ostomy creation [107,108]. Future studies should also focus on the risk and benefits of prophylactic mesh placement while taking into account specific patient or operative factors, such as obesity or an emergent operation, which increases the risk of not only a parastomal hernia but also wound infection and subsequently mesh infection.…”

Parastomal Hernia

“…Stoma relocation is another choice for repair of PSH, and it is associated with a high recurrence rate (range, 24-86%), morbidity rate (23%), and an additional risk of incisional hernia development in the midline or at the old ostomy site of 20% [4,8,34]. This technique usually requires a formal laparotomy or peristomal incision, dissection of the PSH along with other parts of the bowel, and mobilization of the intestine to enable stoma repositioning [18].…”

“…Thus, the prevention of PSH occurrence from the very beginning, at the time of stoma creation, appears to be more rational and ideal approach than repairing the defect [1,4,8,10,[33][34][35]38]. This method was irst implemented by Bayer et al in the late 1980s and favorable short-and long-term outcomes have been reported [2,3].…”