Prevention of Hernia After Loop Ileostomy Reversal
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 208
- Locations
- 5
- Primary Endpoint
- Hernia
Study Overview
Brief Summary
PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery are randomized between retro muscular mesh Ultrapro Advanced or standard treatment without mesh.
Detailed Description
A temporary loop ileostomy is widely used when operating rectal cancer. The ostomy is then reversed in a separate operation. Morbidity of stoma reversal is significant, but not clearly defined. One complication in connection with stoma closure is development of hernia at the former stoma site.
A hernia is a weakening of the muscular layers and the connective tissue of the abdominal wall, which may cause pain and discomfort, as well as an inconvenient bulge. A hernia could also cause more serious complication of obstructed or strangulated bowel. According to international studies, the incidence of hernia at the ostomy site varies between 7% and 35%. Many of the studies are heterogenic and some of them include both colostomies and ileostomies. Among studies that focus on reversal of ileotomies the hernia incidence varies between 11-15%. Preliminary results from a retrospective study in Stockholm indicates a frequency of 7,9%.
The best method to avoid hernia after stoma closure is not known. Most commonly surgeons tend to close the fascia in one layer with monofilament suture. In the study mentioned above 91% of the operations were done with one-layer monofilament, mostly PDS. Use of prophylactic mesh in the abdominal wall has been proposed, but there is currently insufficient scientific evidence to recommend it as a routine.
The present study is focused on loop ileostomy closure after rectal cancer. A non-heterogenous group of ostomies will serve as a base to evaluate whether the incidence of hernia may be reduced. If this study detects a decreased frequency of hernia when using prophylactic meshes, it may lead to new recommendations for this patient group.
PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery will be randomized to retro muscular mesh Ultrapro Advanced or standard treatment without mesh. Operating time, complications, LOS, pain, infections and postoperative hernia are to be studied. The patients will be identified and asked about participation when they come for postoperative control after rectal cancer operation and are planned for the ileostomy reversal after check of the rectal anastomosis. They will be given oral and written information and signed informed consent is required from all patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The patient and the surgeon performing the follow-up are masked for the allocation
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients operated for low anterior resection for rectal cancer with a diverting loop ileostomy and planned for stoma reversal
Exclusion Criteria
- •Language barrier or cognitive disability
- •Recurrent cancer
Arms & Interventions
Mesh reinforcement
Retro muscular mesh at the stoma site.
Intervention: Mesh reinforcement (Combination Product)
No reinforcement
Standard closure of the abdominal wall
Intervention: No reinforcement (Other)
Outcomes
Primary Outcomes
Hernia
Time Frame: One year
Hernia at the site of the stomal closure
Secondary Outcomes
- Postoperative complications(Thirty days)
- Operation time(Three hours)
- Time for closing the stoma site(One hour)
- Hospital stay(Seven days)
- Postoperative pain(Thirty days)
Investigators
Åsa Hallqvist Everhov
MD, PhD
Karolinska Institutet
