Back to resultsPrevention of Parastomal Hernia With a Mesh
Primary Purpose
Parastomal Hernia
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Prophylactic mesh
Sponsored by
About this trial
This is an interventional prevention trial for Parastomal Hernia focused on measuring Parastomal hernia, wound infection, stoma care.
Eligibility Criteria
Inclusion Criteria:
- Clinical need of an enterostoma
Exclusion Criteria:
- Patients denies inclusion in the trial.
Sites / Locations
- Kirurgkliniken Sundsvalls sjukhus
Outcomes
Primary Outcome Measures
Wound infection,mesh infection, parastomal hernia.
Secondary Outcome Measures
Fistula formation, stenosis,pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00509054
Brief Title
Prevention of Parastomal Hernia With a Mesh
Official Title
Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sundsvall Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.
Detailed Description
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.
A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.
Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.
Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parastomal Hernia
Keywords
Parastomal hernia, wound infection, stoma care.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Prophylactic mesh
Other Intervention Name(s)
Vypro mesh, Ethicon.
Intervention Description
A low weigth partly absorbable mesh in a subaly posistion
Primary Outcome Measure Information:
Title
Wound infection,mesh infection, parastomal hernia.
Time Frame
Within five years
Secondary Outcome Measure Information:
Title
Fistula formation, stenosis,pain.
Time Frame
Within five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical need of an enterostoma
Exclusion Criteria:
Patients denies inclusion in the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif A Israelsson, MD,PhD
Organizational Affiliation
Umea University
Official's Role
Study Director
Facility Information:
Facility Name
Kirurgkliniken Sundsvalls sjukhus
City
Sundsvall
ZIP/Postal Code
SE-85186
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
15613293
Citation
Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.
Results Reference
result
Learn more about this trial
Prevention of Parastomal Hernia With a Mesh
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