Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh (STOMAMESH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Norrbottens Lans Landsting
Sponsor:
Information provided by (Responsible Party):
Pia Nasvall, Norrbottens Lans Landsting
ClinicalTrials.gov Identifier:
NCT00917995
First received: June 8, 2009
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

Parastomal hernia is a relatively common and troublesome complication in patients with a stoma. The exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. A parastomal hernia may give the patient difficulties with appliance and leakage. From an economical point of view a stoma that requires special kinds of appliances is expensive. Theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. Recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. No negative side effects with the use of a mesh have been reported in these studies. All earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. Complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. To understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial.

Specific aim:

To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.

All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.

If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.


Condition Intervention Phase
Parastomal Hernia
Device: Polypropylene Mesh, density 25-40g/square meter
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

Resource links provided by NLM:


Further study details as provided by Norrbottens Lans Landsting:

Primary Outcome Measures:
  • The number of parastomal hernias in the two groups at 12 and 36 months postoperatively [ Time Frame: At 12 and 36 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life related to health [ Time Frame: At 12 and 36 months postoperatively ] [ Designated as safety issue: Yes ]
  • The health care systems total cost related to the stoma [ Time Frame: At 12 and 36 months postoperatively ] [ Designated as safety issue: Yes ]
  • Rate of infections 30 days postoperatively [ Time Frame: At 30 days postoperatively ] [ Designated as safety issue: Yes ]
  • Late complication related to the mesh leading to surgery [ Time Frame: At 12 and 36 months postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colostomy with a prophylactic mesh Device: Polypropylene Mesh, density 25-40g/square meter
colostomy with a prophylactic hernia mesh
No Intervention: Colostomy without a prophylactic mesh

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively.
  • No previous stoma.
  • Over the age of 18.
  • Informed consent signed by the patient.

Exclusion Criteria:

  • Expected lifetime less then 3 years.
  • Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
  • Previous stoma.
  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: NCT00917995

Contacts
Contact: Pia Nasvall, MD +46920282000 pia.nasvall@nll.se
Contact: Michael Dahlberg, MD PhD +46920282000 michael.dahlberg@nll.se

Locations
Sweden
Sunderby Hospital Recruiting
Lulea, Sweden, 97180
Contact: Pia Nasvall, MD    +46920282000    pia.nasvall@nll.se   
Sponsors and Collaborators
Norrbottens Lans Landsting
Investigators
Study Chair: Michael Dahlberg, MD PhD Dept of Surgery Sunderby Hospital, Luela, Sweden
  More Information

No publications provided

Responsible Party: Pia Nasvall, MD, Norrbottens Lans Landsting
ClinicalTrials.gov Identifier: NCT00917995     History of Changes
Other Study ID Numbers: 07-081M
Study First Received: June 8, 2009
Last Updated: May 12, 2014
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish National Council on Medical Ethics

Keywords provided by Norrbottens Lans Landsting:
parastomal hernia
prophylactic mesh
colostomy
hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014