The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair (CLOSURE)
Primary Purpose
Ventral Hernia
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Closure of hernia defect.
No closure of the hernia defect.
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring ventral hernia
Eligibility Criteria
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
Sites / Locations
- Algemeen Stedelijk Ziekenhuis
- Imelda Hospital
- St Vincentius Hospital
- Ghent University Hospital
- Maria Middelares
- Hôpital Mont Godinne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Closure
Non-Closure
Arm Description
Outcomes
Primary Outcome Measures
Seroma formation after 4 weeks.
The seroma formation is checked by clinical evaluation.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01719718
First Posted
October 30, 2012
Last Updated
August 31, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01719718
Brief Title
The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
Acronym
CLOSURE
Official Title
The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
ventral hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Closure
Arm Type
Active Comparator
Arm Title
Non-Closure
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Closure of hernia defect.
Intervention Description
Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
Intervention Type
Procedure
Intervention Name(s)
No closure of the hernia defect.
Intervention Description
Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).
Primary Outcome Measure Information:
Title
Seroma formation after 4 weeks.
Description
The seroma formation is checked by clinical evaluation.
Time Frame
4 weeks after surgery.
Secondary Outcome Measure Information:
Title
Pain, discomfort and esthetic evaluation after 4 weeks.
Description
Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.
Time Frame
4 weeks after surgery.
Title
Pain, discomfort and esthetic evaluation after 1 year.
Description
Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.
Time Frame
1 year after surgery.
Title
Pain, discomfort and esthetic evaluation after 2 years.
Description
Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.
Time Frame
2 years after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD, PhD, FACS
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algemeen Stedelijk Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
Imelda Hospital
City
Bonheiden
Country
Belgium
Facility Name
St Vincentius Hospital
City
Deinze
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Maria Middelares
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hôpital Mont Godinne
City
Mont-Godinne
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
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