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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: Closure of hernia defect.; Procedure: No closure of the hernia defect.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Algemeen Stedelijk Ziekenhuis
  • Bonheiden, Belgium
    • Imelda Hospital
  • Deinze, Belgium
    • St Vincentius Hospital
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Ghent, Belgium, 9000
    • Maria Middelares
  • Namur, Belgium
    • Hôpital Mont Godinne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Closure	Procedure: Closure of hernia defect.; Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
Sham Comparator: Non-Closure	Procedure: No closure of the hernia defect.; Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma formation after 4 weeks.	The seroma formation is checked by clinical evaluation.	4 weeks after surgery.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Frederik Berrevoet, MD, PhD, FACS, University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimated): November 1, 2012

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ventral hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Recurrence; Hernia, Ventral
• Other Study ID Numbers: 2012/075