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

July 9, 2008 updated by: University Hospital, Gentofte, Copenhagen

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Medical and surgical complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: Jacob Rosenberg, Prof, MD, Gentofte University Hospital, Dept. of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

July 11, 2008

Last Update Submitted That Met QC Criteria

July 9, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA05102m

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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