Prevention of Parastomal Hernia With a Mesh

Sundsvall Hospital

Status and phase: Completed; Phase 4

Conditions: Parastomal Hernia

Treatments: Procedure: Prophylactic mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00509054

Preventing parastomal hernia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical need of an enterostoma

Exclusion criteria

• Patients denies inclusion in the trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind