The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair (CLOSURE)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Ventral Hernia

Treatments: Procedure: Closure of hernia defect.; Procedure: No closure of the hernia defect.

Study type: Interventional

Funder types: Other

Identifiers

NCT01719718

2012/075

Details and patient eligibility

About

A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent from the patient or his/her legal representative
• Ventral or incisional hernia requiring elective surgical repair
• Diameter between 2 and 5cm in width
• Midline and flank hernias are eligible

Exclusion criteria

• No written informed consent
• 'Hostile' abdomen, open abdomen treatment
• Contraindication to pneumoperitoneum
• Emergency surgery (incarcerated hernia)
• Parastomal hernia
• Subxiphoidal hernia
• Subcostal hernia
• Suprapubic hernia
• Clean-contaminated or contaminated field
• Hernia diameter >5cm in width
• Pregnancy
• Non-compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Closure

Active Comparator group

Treatment:

Procedure: Closure of hernia defect.

Non-Closure

Sham Comparator group

Treatment:

Procedure: No closure of the hernia defect.