Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)

This study has been completed.
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center Identifier:
First received: August 18, 2011
Last updated: August 19, 2011
Last verified: August 2011

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.

Condition Intervention Phase
Postoperative Pain
Procedure: incisional hernia repair
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial

Resource links provided by NLM:

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative analgesics use [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • operation time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: May 1999
Study Completion Date: July 2011
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01420757

Sponsors and Collaborators
Erasmus Medical Center
Principal Investigator: J.F. Lange, MD, PhD Erasmus Medical Center
  More Information

No publications provided

Responsible Party: hasan eker, Prof. Dr. J.F. Lange, Erasmus Medical Center Identifier: NCT01420757     History of Changes
Other Study ID Numbers: COLIBRI trial 
Study First Received: August 18, 2011
Last Updated: August 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
operation time
length of hospital stay

Additional relevant MeSH terms:
Pain, Postoperative
Disease Attributes
Pathologic Processes
Postoperative Complications
Signs and Symptoms processed this record on February 04, 2016