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NCT01719718 Clinical Trial

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

Ventral Hernia Clinical Trial

— CLOSURE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01719718
Other study ID # 2012/075
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date December 31, 2023

Study information
Verified date May 2024
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date December 31, 2023
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Closure of hernia defect.
Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
• No closure of the hernia defect.
Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).

Locations
Country Name City State
Belgium Algemeen Stedelijk Ziekenhuis Aalst
Belgium Imelda Hospital Bonheiden
Belgium St Vincentius Hospital Deinze
Belgium Ghent University Hospital Ghent
Belgium Maria Middelares Ghent
Belgium Hôpital Mont Godinne Namur

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seroma formation after 4 weeks. The seroma formation is checked by clinical evaluation. 4 weeks after surgery.
Secondary 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.
Secondary 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.
Secondary 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.
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Terminated NCT01794338 - The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients N/A
Completed NCT01886963 - A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair N/A
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External Links