Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh (STOMAMESH)
Primary Purpose
Parastomal Hernia
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Polypropylene Mesh, density 25-40g/square meter
Sponsored by
About this trial
This is an interventional prevention trial for Parastomal Hernia focused on measuring parastomal hernia, prophylactic mesh, colostomy, hernia
Eligibility Criteria
Inclusion Criteria:
- Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively.
- No previous stoma.
- Over the age of 18.
- Informed consent signed by the patient.
Exclusion Criteria:
- Expected lifetime less then 3 years.
- Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
- Previous stoma.
Sites / Locations
- Sunderby Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Colostomy with a prophylactic mesh
Colostomy without a prophylactic mesh
Arm Description
Outcomes
Primary Outcome Measures
The number of parastomal hernias in the two groups at 12 and 36 months postoperatively
Secondary Outcome Measures
Quality of life related to health
The health care systems total cost related to the stoma
Rate of infections 30 days postoperatively
Late complication related to the mesh leading to surgery
Full Information
NCT ID
NCT00917995
First Posted
June 8, 2009
Last Updated
October 14, 2015
Sponsor
Norrbottens Lans Landsting
1. Study Identification
Unique Protocol Identification Number
NCT00917995
Brief Title
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
Acronym
STOMAMESH
Official Title
STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norrbottens Lans Landsting
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Specific aim:
To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.
All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.
If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.
Detailed Description
Parastomal hernia is a relatively common and troublesome complication in patients with a stoma. The exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. A parastomal hernia may give the patient difficulties with appliance and leakage. From an economical point of view a stoma that requires special kinds of appliances is expensive. Theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. Recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. No negative side effects with the use of a mesh have been reported in these studies. All earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. Complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. To understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial.
Specific aim:
To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.
All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.
If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parastomal Hernia
Keywords
parastomal hernia, prophylactic mesh, colostomy, hernia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colostomy with a prophylactic mesh
Arm Type
Experimental
Arm Title
Colostomy without a prophylactic mesh
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Polypropylene Mesh, density 25-40g/square meter
Intervention Description
colostomy with a prophylactic hernia mesh
Primary Outcome Measure Information:
Title
The number of parastomal hernias in the two groups at 12 and 36 months postoperatively
Time Frame
At 12 and 36 months postoperatively
Secondary Outcome Measure Information:
Title
Quality of life related to health
Time Frame
At 12 and 36 months postoperatively
Title
The health care systems total cost related to the stoma
Time Frame
At 12 and 36 months postoperatively
Title
Rate of infections 30 days postoperatively
Time Frame
At 30 days postoperatively
Title
Late complication related to the mesh leading to surgery
Time Frame
At 12 and 36 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively.
No previous stoma.
Over the age of 18.
Informed consent signed by the patient.
Exclusion Criteria:
Expected lifetime less then 3 years.
Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
Previous stoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dahlberg, MD PhD
Organizational Affiliation
Dept of Surgery Sunderby Hospital, Luela, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Sunderby Hospital
City
Lulea
ZIP/Postal Code
97180
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
31392405
Citation
Naverlo S, Gunnarsson U, Strigard K, Nasvall P. Quality of life after end colostomy without mesh and with prophylactic synthetic mesh in sublay position: one-year results of the STOMAMESH trial. Int J Colorectal Dis. 2019 Sep;34(9):1591-1599. doi: 10.1007/s00384-019-03359-2. Epub 2019 Aug 7.
Results Reference
derived
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Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
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