The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
CLOSURE
1 other identifier
interventional
93
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 30, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 17, 2024
May 1, 2024
3.2 years
October 30, 2012
May 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroma formation after 4 weeks.
The seroma formation is checked by clinical evaluation.
4 weeks after surgery.
Secondary Outcomes (3)
Pain, discomfort and esthetic evaluation after 4 weeks.
4 weeks after surgery.
Pain, discomfort and esthetic evaluation after 1 year.
1 year after surgery.
Pain, discomfort and esthetic evaluation after 2 years.
2 years after surgery.
Study Arms (2)
Closure
ACTIVE COMPARATORNon-Closure
SHAM COMPARATORInterventions
Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium
Imelda Hospital
Bonheiden, Belgium
St Vincentius Hospital
Deinze, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Maria Middelares
Ghent, 9000, Belgium
Hôpital Mont Godinne
Namur, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederik Berrevoet, MD, PhD, FACS
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2012
First Posted
November 1, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 31, 2023
Last Updated
May 17, 2024
Record last verified: 2024-05