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Prevention of Parastomal Hernia by Primary Mesh Insertion

Primary Purpose

Parastomal Hernia

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
onlay mesh
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parastomal Hernia focused on measuring Parastomal hernia, Onlay mesh, Sublay mesh, Pain, Health questionnaire

Eligibility Criteria

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

Inclusion Criteria:

  • Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion Criteria:

  • ASA > 3
  • Acute surgery
  • Known immune deficiency
  • Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
  • Pregnancy
  • Known inflammatory bowel disease
  • Lack of written informed consent

Sites / Locations

  • Copenhagen University Hospital, Hvidovre
  • Copenhagen University Hospital, Gentofte

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

onlay mesh

sublay mesh

no mesh

Arm Description

Outcomes

Primary Outcome Measures

Parastomal hernia verified by CT-scan

Secondary Outcome Measures

Clinically detected parastomal hernia
Pain
Disease specific and general health questionnaire

Full Information

First Posted
March 18, 2008
Last Updated
February 6, 2014
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Aarhus University Hospital, Hvidovre University Hospital, Copenhagen University Hospital at Herlev, Hospital of South West Jutland, Hillerod Hospital, Denmark, Vejle Hospital, Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00641342
Brief Title
Prevention of Parastomal Hernia by Primary Mesh Insertion
Official Title
Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment from different study sites and due to structural changes in the included centers
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Aarhus University Hospital, Hvidovre University Hospital, Copenhagen University Hospital at Herlev, Hospital of South West Jutland, Hillerod Hospital, Denmark, Vejle Hospital, Zealand University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parastomal Hernia
Keywords
Parastomal hernia, Onlay mesh, Sublay mesh, Pain, Health questionnaire

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
onlay mesh
Arm Type
Active Comparator
Arm Title
sublay mesh
Arm Type
Active Comparator
Arm Title
no mesh
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
onlay mesh
Intervention Description
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
Primary Outcome Measure Information:
Title
Parastomal hernia verified by CT-scan
Time Frame
one year after surgery, reassessed after 2, 3 and 5 years
Secondary Outcome Measure Information:
Title
Clinically detected parastomal hernia
Time Frame
one year after surgery, reassessed after 2, 3 and 5 years
Title
Pain
Time Frame
one year after surgery, reassessed after 2, 3 and 5 years
Title
Disease specific and general health questionnaire
Time Frame
one year after surgery, reassessed after 2, 3 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure. Exclusion Criteria: ASA > 3 Acute surgery Known immune deficiency Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months. Pregnancy Known inflammatory bowel disease Lack of written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Gögenur
Organizational Affiliation
University Hospital of Copenhagen, GEntofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital, Hvidovre
City
Hvidovre
State/Province
Copebhagen
ZIP/Postal Code
2630
Country
Denmark
Facility Name
Copenhagen University Hospital, Gentofte
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Prevention of Parastomal Hernia by Primary Mesh Insertion

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