Laparoscopic Versus Open Incisional Hernia Repair (COLIBRI)

Erasmus University

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Complications; Recurrence

Treatments: Procedure: incisional hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01420757

COLIBRI trial

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

open

Active Comparator group

Description:

open incisional hernia repair

Treatment:

Procedure: incisional hernia repair

laparoscopic

Active Comparator group

Description:

laparoscopic incisional hernia repair

Treatment:

Procedure: incisional hernia repair