Peristomal Mesh for Prophylaxis of Parastomal Hernia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00496418
First received: July 3, 2007
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.


Condition Intervention Phase
Hernia
Device: Mesh in permanent colostomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Parastomal hernia [ Time Frame: at 3, 12, 24, 36 and 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2007
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylactic stoma mesh
Mesh
Device: Mesh in permanent colostomy
Active Comparator: No mesh prophylaxis
No mesh
Device: Mesh in permanent colostomy

Detailed Description:

Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.

Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Condition with indication for establishing a permanent end-colostomy.

Exclusion Criteria:

  • Age under 18
  • ASA score above 3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496418

Locations
Norway
Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, NO-0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Jan Lambrecht, MD Rikshospitalet-Radiumhospitalet HF, Medical Center
  More Information

No publications provided

Responsible Party: Jan Lambrecht, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00496418     History of Changes
Other Study ID Numbers: S-07203a
Study First Received: July 3, 2007
Last Updated: January 25, 2013
Health Authority: Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
colostomy
parastomal
peristomal
hernia
mesh
surgery
Indication for permanent end colostomy

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 19, 2014