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Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420757
First Posted: August 22, 2011
Last Update Posted: August 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 hasan eker, Erasmus Medical Center:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Postoperative analgesics use [ Time Frame: 1 week ]
  • complications [ Time Frame: 4 weeks ]
  • operation time [ Time Frame: 1 day ]
  • length of hospital stay [ Time Frame: 4 weeks ]
  • recurrence [ Time Frame: 5 years ]
  • mortality [ Time Frame: 5 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420757


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

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
First Submitted: August 18, 2011
First Posted: August 22, 2011
Last Update Posted: August 22, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
Pain, Postoperative
Recurrence
Incisional Hernia
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Disease Attributes
Hernia
Pathological Conditions, Anatomical