The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair (CLOSURE)
This study is currently recruiting participants.
Verified October 2012 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01719718
First received: October 30, 2012
Last updated: October 31, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ventral Hernia |
Procedure: Closure of hernia defect. Procedure: No closure of the hernia defect. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair. |
Resource links provided by NLM:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Seroma formation after 4 weeks. [ Time Frame: 4 weeks after surgery. ] [ Designated as safety issue: No ]The seroma formation is checked by clinical evaluation.
Secondary Outcome Measures:
- Pain, discomfort and esthetic evaluation after 4 weeks. [ Time Frame: 4 weeks after surgery. ] [ Designated as safety issue: No ]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. [ Time Frame: 1 year after surgery. ] [ Designated as safety issue: No ]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. [ Time Frame: 2 years after surgery. ] [ Designated as safety issue: No ]Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.
| Estimated Enrollment: | 132 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719718
Contacts
| Contact: Frederik Berrevoet, MD, PhD | Frederik.Berrevoet@ugent.be |
Locations
| Belgium | |
| Algemeen Stedelijk Ziekenhuis | Recruiting |
| Aalst, Belgium | |
| Contact: Van Den Bossche, MD | |
| Principal Investigator: Van Den Bossche, MD | |
| Imelda Hospital | Recruiting |
| Bonheiden, Belgium | |
| Contact: Tollens, MD | |
| Principal Investigator: Tollens, MD | |
| St Vincentius Hospital | Recruiting |
| Deinze, Belgium | |
| Contact: Berwouts, MD | |
| Principal Investigator: Berwouts, MD | |
| Ghent University Hospital | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Frederik Berrevoet, MD, PhD Frederik.Berrevoet@ugent.be | |
| Principal Investigator: Frederik Berrevoet, MD, PhD, FACS | |
| Sub-Investigator: Aude Vanlander, MD | |
| Maria Middelares | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Muysoms, MD | |
| Principal Investigator: Muysoms, MD | |
| Hôpital Mont Godinne | Recruiting |
| Mont-Godinne, Belgium | |
| Contact: Betrand, MD | |
| Principal Investigator: Bertrand, MD | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Frederik Berrevoet, MD, PhD, FACS | Ghent University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01719718 History of Changes |
| Other Study ID Numbers: | 2012/075 |
| Study First Received: | October 30, 2012 |
| Last Updated: | October 31, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Hospital, Ghent:
|
ventral hernia |
Additional relevant MeSH terms:
|
Hernia Hernia, Ventral Recurrence Pathological Conditions, Anatomical |
Hernia, Abdominal Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013