Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01420757
First received: August 18, 2011
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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
Complications
Recurrence
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420757

Sponsors and Collaborators
Erasmus Medical Center
Investigators
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
ClinicalTrials.gov 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:
Hernia
Pain, Postoperative
Recurrence
Hernia, Ventral
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Disease Attributes
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 16, 2014