Laparoscopic Versus Open Incisional Hernia Repair

Postoperative Pain Clinical Trial

— COLIBRI  

Official title:

Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420757
• Other study ID #: COLIBRI trial
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2011
• Last updated: August 19, 2011
• Start date: May 1999
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: July 2011
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications
• Pain, Postoperative
• Postoperative Pain
• Recurrence

Intervention

Procedure:
• incisional hernia repair
Tension-free open or laparoscopic incisional hernia repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain		4 weeks	No
Secondary	Postoperative analgesics use		1 week	No
Secondary	complications		4 weeks	Yes
Secondary	operation time		1 day	No
Secondary	length of hospital stay		4 weeks	No
Secondary	recurrence		5 years	No
Secondary	mortality		5 years	No