Prevention of Parastomal Hernia With a Mesh

Phase 4

Completed

• Conditions: Parastomal Hernia

• Registration Number: NCT00509054
• Lead Sponsor: Sundsvall Hospital

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.

Study Timeline

• Status Verified: 2001-01
• Study Start: 2001-01
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Clinical need of an enterostoma

Exclusion Criteria

• Patients denies inclusion in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound infection,mesh infection, parastomal hernia.	Within five years

Secondary Outcome Measures

Name	Time	Method
Fistula formation, stenosis,pain.	Within five years

Trial Locations

Locations (1)

Kirurgkliniken Sundsvalls sjukhus; 🇸🇪 Sundsvall, Sweden