NCT03667287

Stoma Hernia Intraperitoneal Full-Thickness Skin

Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.

Detailed description

Parastomal hernia is a common complication to a stoma which can cause considerable suffering for the patient. The conventional methods of repair available today have disappointing results with high recurrence rates and serious complications. Some of the complications can be related to the introduction of foreign material into the abdominal wall. The investigators hypothesis is that the use of autologous full-thickness skin graft as reinforcement material can offer an alternative with fewer complications and recurrences. Patients with symptomatic parastomal hernia will be included in a prospective randomized multicenter study comparing reinforcement with conventional synthetic mesh (with the best available technique today), to full thickness skin grafts placed in an intraperitoneal position. The intervention will be blinded to the participants, nursing staff and the follow-up staff. The participants will be followed up at 3, 12 and 36 months monitoring complications, recurrences, quality of life, strength of the abdomino-lumbar girdle and calculations will be done on the health economics.

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
PROCEDURE	Repair of parastomal hernia	Surgical repair of symptomatic parastomal hernia.

Timeline

• Start date: 2018-01-23
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2018-09-12
• Last updated: 2019-05-01

Locations

2 sites across 1 country: Sweden