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OpenTrials
Completed

NCT Number: NCT01420757

Laparoscopic Versus Open Incisional Hernia Repair

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.

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Key information

Conditions

Postoperative Pain Complications Disease Attributes Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Recurrence Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incisional hernia repair

Procedure

Tension-free open or laparoscopic incisional hernia repair

Primary outcomes

  1. Postoperative pain

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial

Acronym: COLIBRI

Important dates

Study start
1999
Primary completion
2006
Study completion
2011
First posted
Aug 22, 2011
Registry last updated
Aug 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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