Prevention of Parastomal Hernia by Primary Mesh Insertion

Parastomal Hernia Clinical Trial

Official title:

Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00641342
• Other study ID #: PMPC
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 18, 2008
• Last updated: February 6, 2014
• Start date: March 2007
• Est. completion date: February 2015

Study information

• Verified date: March 2008
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 198
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion Criteria:

• ASA > 3

• Acute surgery

• Known immune deficiency

• Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.

• Pregnancy

• Known inflammatory bowel disease

• Lack of written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Device:
• onlay mesh
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Gentofte	Hellerup	Copenhagen
Denmark	Copenhagen University Hospital, Hvidovre	Hvidovre	Copebhagen

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Aarhus University Hospital, Copenhagen University Hospital at Herlev, Hillerod Hospital, Denmark, Hvidovre University Hospital, Roskilde County Hospital, Sydvestjysk Hospital, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parastomal hernia verified by CT-scan		one year after surgery, reassessed after 2, 3 and 5 years	No
Secondary	Clinically detected parastomal hernia		one year after surgery, reassessed after 2, 3 and 5 years	No
Secondary	Pain		one year after surgery, reassessed after 2, 3 and 5 years	No
Secondary	Disease specific and general health questionnaire		one year after surgery, reassessed after 2, 3 and 5 years	No