Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

Parastomal Hernia Clinical Trial

— STOMAMESH  

Official title:

STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917995
• Other study ID #: 07-081M
• 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

• Hernia
• Parastomal Hernia

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