We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)

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.
ClinicalTrials.gov Identifier: NCT01420757
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : August 22, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Pain Complications Recurrence Procedure: incisional hernia repair Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
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
Study Start Date : May 1999
Primary Completion Date : December 2006
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: August 22, 2011    Key Record Dates
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