Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)

August 19, 2011 updated by: hasan eker, Erasmus Medical Center

Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial

Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.

The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hernia diameter between 3 and 15 cm
  • location at the ventral abdominal wall at least 5cm from costae and inguinal area
  • indication for elective repair
  • age of 18 years or older
  • written informed consent.

Exclusion Criteria:

  • contraindication for pneumoperitoneum
  • an absolute contraindication for general anesthesia
  • history of open abdomen treatment
  • patients participating in other trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open
open incisional hernia repair
Procedure: incisional hernia repair
Tension-free open or laparoscopic incisional hernia repair
Active Comparator: laparoscopic
laparoscopic incisional hernia repair
Procedure: incisional hernia repair
Tension-free open or laparoscopic incisional hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
length of hospital stay
Time Frame: 4 weeks
4 weeks
mortality
Time Frame: 5 years
5 years
recurrence
Time Frame: 5 years
5 years
Postoperative analgesics use
Time Frame: 1 week
1 week
complications
Time Frame: 4 weeks
4 weeks
operation time
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Estimate)

August 22, 2011

Last Update Submitted That Met QC Criteria

August 19, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLIBRI trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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