Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life.

Detailed Description
-----------------
Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hernia. Symptoms associated with parastomal hernias goes from mild physical (pain) and cosmetic discomfort to life threatening conditions with obstruction, strangulation and perforation. Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem. The surgical treatment of parastomal hernias is controversial. The best way to treat it is to restore the continuity of the intestine, but in permanent stomas, this is not an option. Many surgical techniques have been described when intervention is required, but the results are unacceptable. The traditional open techniques are local simple suturing of the fascia defect, stoma relocation, or repair with a prosthetic material either intraperitoneally or extraperitoneally (subfascial or onlay). Overall, the results of all methods are poor with high recurrence rates and high morbidity and mortality. Mesh repair has the lowest recurrence rate (0-39%) and stoma relocation and simple suture has reported recurrence rates on 0-76% and 46-100%, respectively. Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series. The results so far are encouraging, but the follow-up period is short. Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall, we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future. Therefore, we find it interesting to investigate the technique in a prospective study

Official Title
-----------------
Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study

Conditions
-----------------
Hernia, Abdominal Hernia

Intervention / Treatment
-----------------
* Procedure: Laparoscopic parastomal hernia repair with mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 80 years Indication for laparoscopic parastomal hernia repair in general anaesthesia. Danish speaking ASA group I-III No remaining malignancy after former primary radical operation for colorectal cancer Exclusion Criteria: Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation Incarcerated hernia (acute operation) History of abuse or permanent morphine use Expected bad compliance Current systemic steroid use or other immuno-suppressive treatment HIV-positive, pregnant or breast feeding Medical conditions contraindicating general anaesthesia Simultaneous operation for other ventral, inguinal or umbilical hernia Epidural or spinal anaesthesia Conversion to open procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic parastomal hernia repair with mesh|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of parastomal hernia after 6 months (ultrasound and clinical) |  |  | 
| Postoperative pain (Visual Analog Scale, VAS 0-100, Verbal Rating Scale, VRS 0-3) |  |  | 
| Stricture of stoma (Bougie, mm) |  |  | 
| Quality of life (SF-36 and Ostomy Adjustment Scale (OAS)) |  |  | 
| General well-being (VAS 0-100) |  |  | 
| Postoperative ileus/paralysis > 24 hours |  |  | 
| Patient's satisfaction (VAS 0-100) |  |  | 
| Bandage problems (VRS 0-3) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical and surgical complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic parastomal hernia repair, Intraperitoneally, Mesh, Quality of life, Postoperative pain, Recurrence