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

NCT00917995 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2015-10-16

No results posted yet for this study

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.

Conditions

  • Parastomal Hernia

Interventions

DEVICE

Polypropylene Mesh, density 25-40g/square meter

colostomy with a prophylactic hernia mesh

Sponsors & Collaborators

  • Norrbottens Lans Landsting

    lead OTHER

Principal Investigators

  • Michael Dahlberg, MD PhD · Dept of Surgery Sunderby Hospital, Luela, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00917995 on ClinicalTrials.gov