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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00917995
Other study ID # 07-081M
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 8, 2009
Last updated October 14, 2015
Start date January 2008
Est. completion date September 2015

Study information

Verified date October 2015
Source Norrbottens Lans Landsting
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical Ethics
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 241
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Polypropylene Mesh, density 25-40g/square meter
colostomy with a prophylactic hernia mesh

Locations

Country Name City State
Sweden Sunderby Hospital Lulea

Sponsors (1)

Lead Sponsor Collaborator
Norrbottens Lans Landsting

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of parastomal hernias in the two groups at 12 and 36 months postoperatively At 12 and 36 months postoperatively No
Secondary Quality of life related to health At 12 and 36 months postoperatively Yes
Secondary The health care systems total cost related to the stoma At 12 and 36 months postoperatively Yes
Secondary Rate of infections 30 days postoperatively At 30 days postoperatively Yes
Secondary Late complication related to the mesh leading to surgery At 12 and 36 months postoperatively Yes
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