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

Primary Purpose

Hernia, Abdominal Hernia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic parastomal hernia repair with mesh
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring Laparoscopic parastomal hernia repair, Intraperitoneally, Mesh, Quality of life, Postoperative pain, Recurrence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    August 29, 2005
    Last Updated
    July 9, 2008
    Sponsor
    University Hospital, Gentofte, Copenhagen
    Collaborators
    Ethicon, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00138957
    Brief Title
    Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
    Official Title
    Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    too few patients included
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2007 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Gentofte, Copenhagen
    Collaborators
    Ethicon, Inc.

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hernia, Abdominal Hernia
    Keywords
    Laparoscopic parastomal hernia repair, Intraperitoneally, Mesh, Quality of life, Postoperative pain, Recurrence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic parastomal hernia repair with mesh
    Primary Outcome Measure Information:
    Title
    Recurrence of parastomal hernia after 6 months (ultrasound and clinical)
    Title
    Postoperative pain (Visual Analog Scale, VAS 0-100, Verbal Rating Scale, VRS 0-3)
    Title
    Stricture of stoma (Bougie, mm)
    Title
    Quality of life (SF-36 and Ostomy Adjustment Scale (OAS))
    Title
    General well-being (VAS 0-100)
    Title
    Postoperative ileus/paralysis > 24 hours
    Title
    Patient's satisfaction (VAS 0-100)
    Title
    Bandage problems (VRS 0-3)
    Secondary Outcome Measure Information:
    Title
    Medical and surgical complications

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jacob Rosenberg, Prof, MD
    Organizational Affiliation
    Gentofte University Hospital, Dept. of Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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