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Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)

Primary Purpose

Postoperative Pain, Complications, Recurrence

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
incisional hernia repair
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring operation time, length of hospital stay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    open

    laparoscopic

    Arm Description

    open incisional hernia repair

    laparoscopic incisional hernia repair

    Outcomes

    Primary Outcome Measures

    Postoperative pain

    Secondary Outcome Measures

    Postoperative analgesics use
    complications
    operation time
    length of hospital stay
    recurrence
    mortality

    Full Information

    First Posted
    August 18, 2011
    Last Updated
    August 19, 2011
    Sponsor
    Erasmus Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01420757
    Brief Title
    Laparoscopic Versus Open Incisional Hernia Repair
    Acronym
    COLIBRI
    Official Title
    Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1999 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Erasmus Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Complications, Recurrence
    Keywords
    operation time, length of hospital stay

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    206 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    open
    Arm Type
    Active Comparator
    Arm Description
    open incisional hernia repair
    Arm Title
    laparoscopic
    Arm Type
    Active Comparator
    Arm Description
    laparoscopic incisional hernia repair
    Intervention Type
    Procedure
    Intervention Name(s)
    incisional hernia repair
    Intervention Description
    Tension-free open or laparoscopic incisional hernia repair
    Primary Outcome Measure Information:
    Title
    Postoperative pain
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Postoperative analgesics use
    Time Frame
    1 week
    Title
    complications
    Time Frame
    4 weeks
    Title
    operation time
    Time Frame
    1 day
    Title
    length of hospital stay
    Time Frame
    4 weeks
    Title
    recurrence
    Time Frame
    5 years
    Title
    mortality
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    J.F. Lange, MD, PhD
    Organizational Affiliation
    Erasmus Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Laparoscopic Versus Open Incisional Hernia Repair

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