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

NCT ID: NCT00917995

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Parastomal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Colostomy with a prophylactic mesh

Group Type: EXPERIMENTAL

Polypropylene Mesh, density 25-40g/square meter

Intervention Type: DEVICE

colostomy with a prophylactic hernia mesh

Colostomy without a prophylactic mesh

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Polypropylene Mesh, density 25-40g/square meter

colostomy with a prophylactic hernia mesh

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norrbottens Lans Landsting

OTHER

Sponsor Role: lead

Responsible Party

Pia Nasvall

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Dahlberg, MD PhD

Role: STUDY_CHAIR

Dept of Surgery Sunderby Hospital, Luela, Sweden

Locations

Sunderby Hospital

Luleå, , Sweden

Countries

Sweden

References

Naverlo S, Gunnarsson U, Strigard K, Nasvall P. Quality of life after end colostomy without mesh and with prophylactic synthetic mesh in sublay position: one-year results of the STOMAMESH trial. Int J Colorectal Dis. 2019 Sep;34(9):1591-1599. doi: 10.1007/s00384-019-03359-2. Epub 2019 Aug 7.

Reference Type: DERIVED

PMID: 31392405 (View on PubMed)

Other Identifiers

07-081M

Identifier Type: -

Identifier Source: org_study_id