Prevention of Parastomal Hernia With a Mesh

Parastomal Hernia Clinical Trial

Official title:

Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509054
• Other study ID #: Preventing parastomal hernia
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2007
• Last updated: April 15, 2008
• Start date: January 2001
• Est. completion date: July 2007

Study information

• Verified date: January 2001
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Clinical need of an enterostoma

Exclusion Criteria:

• Patients denies inclusion in the trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Procedure:
• Prophylactic mesh
A low weigth partly absorbable mesh in a subaly posistion

Locations

Country	Name	City	State
Sweden	Kirurgkliniken Sundsvalls sjukhus	Sundsvall

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Jänes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound infection,mesh infection, parastomal hernia.		Within five years
Secondary	Fistula formation, stenosis,pain.		Within five years