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

Not Applicable

Completed

• Conditions: Ventral Hernia
• Interventions: Procedure: Closure of hernia defect.; Procedure: No closure of the hernia defect.

• Registration Number: NCT01719718
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-01
• Primary Completion: 2015-12
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closure	Closure of hernia defect.	-
Non-Closure	No closure of the hernia defect.	-

Primary Outcome Measures

Name	Time	Method
Seroma formation after 4 weeks.	4 weeks after surgery.	The seroma formation is checked by clinical evaluation.

Secondary Outcome Measures

Name	Time	Method
Pain, discomfort and esthetic evaluation after 2 years.	2 years after surgery.	Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.
Pain, discomfort and esthetic evaluation after 4 weeks.	4 weeks after surgery.	Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.
Pain, discomfort and esthetic evaluation after 1 year.	1 year after surgery.	Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.

Trial Locations

Locations (6)

St Vincentius Hospital; 🇧🇪 Deinze, Belgium

Hôpital Mont Godinne; 🇧🇪 Namur, Belgium

Imelda Hospital; 🇧🇪 Bonheiden, Belgium

Algemeen Stedelijk Ziekenhuis; 🇧🇪 Aalst, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium

Maria Middelares; 🇧🇪 Ghent, Belgium