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Clinical Trials/NCT03720262
NCT03720262RecruitingPhase 2

Prevention of Hernia After Loop Ileostomy Reversal

Karolinska Institutet5 sites in 1 country208 target enrollmentStarted: March 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
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

Experimental

Retro muscular mesh at the stoma site.

Intervention: Mesh reinforcement (Combination Product)

No reinforcement

Placebo Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Åsa Hallqvist Everhov

MD, PhD

Karolinska Institutet

Study Sites (5)

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