Stoma Hernia Intraperitoneal Full-Thickness Skin

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

Detailed Description
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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.

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

Conditions
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Parastomal Hernia

Intervention / Treatment
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* Procedure: Repair of parastomal hernia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colo-, ileo- or urostomy Parastomal hernia diagnosed with intrastomal ultrasound and/or CT Symptoms from the parastomal hernia requiring surgical intervention Informed consent >18 years of age Sufficient knowledge in the Swedish language so that questionnaires can be answered Exclusion Criteria: Cognitive impairment unabling compliance to post-operative prescriptions and/or answering questionnaires Insufficient amount of good quality skin suitable for transplantation Expected high donor-site morbidity Fistula/e adjacent to stoma Mb Crohn

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-thickness skin graft<br>Repair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement. | Procedure: Repair of parastomal hernia<br>* Surgical repair of symptomatic parastomal hernia.<br>|
| Active Comparator: Synthethic mesh<br>Repair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement | Procedure: Repair of parastomal hernia<br>* Surgical repair of symptomatic parastomal hernia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications at 3 months | Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation. | 3 month post-operative clinical follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Parastomal hernia recurrence measured clinically, with stomal ultrasound and/or computerized tomography. | 3, 12 and 36 months | 
| Pain - VHPQ | All subjects will complete Ventral Hernia Pain Questionaire (VHPQ) to assess and compare pre- and postoperative pain. | 3, 12 and 36 months. | 
| QoL - EORTC CR29 | All subject will complete European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer (EORTC CR29) as a complement to EORTC C30, to assess and compare pre- and postoperative quality of life. | 3, 12 and 36 months. | 
| QoL - EORTC C30 | All subject will complete European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC CR30) to assess and compare pre- and postoperative quality of life. | 3, 12 and 36 months. | 
| Abdominal strength | Strength of the abdomino-lumbar girdle measured in Biodex-4. | 12 and 36 months. | 
| Health economics | Cost-effectiveness of the separate procedures. The total cost of each method will be calculated from the hospital economic systems including duration of surgery, cost of operating time and equipment as well as duration and cost of anesthesia. | 12 and 36 months. | 
| Rate of complications at 12 months | Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation. | 12 month post-operative clinical follow-up | 
| Rate of complications at 36 months | Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation. | 36 month post-operative clinical follow-up |