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

This study has been withdrawn prior to enrollment.
(too few patients included)
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00138957
First received: August 29, 2005
Last updated: July 9, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention
Hernia
Abdominal Hernia
 Procedure: Laparoscopic parastomal hernia repair with mesh

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • 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:
  • Medical and surgical complications

Estimated Enrollment: 20
Study Start Date: September 2005
Estimated Study Completion Date: December 2007
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138957

Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Ethicon, Inc.
Investigators
Principal Investigator: Jacob Rosenberg, Prof, MD Gentofte University Hospital, Dept. of Surgery
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138957     History of Changes
Other Study ID Numbers: KA05102m
Study First Received: August 29, 2005
Last Updated: July 9, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by University Hospital, Gentofte, Copenhagen:
Laparoscopic parastomal hernia repair
Intraperitoneally
Mesh
 Quality of life
Postoperative pain
Recurrence

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013