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Peristomal Mesh for Prophylaxis of Parastomal Hernia

Primary Purpose

Hernia

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Mesh in permanent colostomy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring colostomy, parastomal, peristomal, hernia, mesh, surgery, Indication for permanent end colostomy

Eligibility Criteria

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

Inclusion Criteria:

  • Condition with indication for establishing a permanent end-colostomy.

Exclusion Criteria:

  • Age under 18
  • ASA score above 3

Sites / Locations

  • Rikshospitalet-Radiumhospitalet HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prophylactic stoma mesh

No mesh prophylaxis

Arm Description

Mesh

No mesh

Outcomes

Primary Outcome Measures

Parastomal hernia

Secondary Outcome Measures

Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy

Full Information

First Posted
July 3, 2007
Last Updated
January 12, 2015
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00496418
Brief Title
Peristomal Mesh for Prophylaxis of Parastomal Hernia
Official Title
Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

5. Study Description

Brief Summary
The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.
Detailed Description
Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation. Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
colostomy, parastomal, peristomal, hernia, mesh, surgery, Indication for permanent end colostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic stoma mesh
Arm Type
Experimental
Arm Description
Mesh
Arm Title
No mesh prophylaxis
Arm Type
Active Comparator
Arm Description
No mesh
Intervention Type
Device
Intervention Name(s)
Mesh in permanent colostomy
Primary Outcome Measure Information:
Title
Parastomal hernia
Time Frame
at 3, 12, 24, 36 and 48 months
Secondary Outcome Measure Information:
Title
Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy
Time Frame
4 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Condition with indication for establishing a permanent end-colostomy. Exclusion Criteria: Age under 18 ASA score above 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Lambrecht, MD
Organizational Affiliation
Rikshospitalet-Radiumhospitalet HF, Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet-Radiumhospitalet HF
City
Oslo
ZIP/Postal Code
NO-0027
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32222841
Citation
Lambrecht JR. Diagnostic methods in parastomal hernia; research and clinical relevance. Hernia. 2021 Jun;25(3):817-820. doi: 10.1007/s10029-020-02177-8. Epub 2020 Mar 28. No abstract available.
Results Reference
derived

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Peristomal Mesh for Prophylaxis of Parastomal Hernia

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