Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET)
This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Collaborator:
Covidien
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01109771
First received: April 22, 2010
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial.
All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventral Hernia |
Device: permanent mesh fixation Device: absorbable mesh fixation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial) |
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:
- number of patients with a VAS scale more than 40 [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- number of invasive interventions (local infiltrations, reoperations) postoperatively [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
- number of patients taking analgetics [ Time Frame: 1 year post-surgery ] [ Designated as safety issue: No ]
- perioperative morbidity rate [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 1 year post-surgery ] [ Designated as safety issue: No ]
- recurrence rate [ Time Frame: 1 year post-surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 440 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: absorbable fixation left side |
Device: permanent mesh fixation
Permanent mesh fixation will be used.
Device: absorbable mesh fixation
Absorbable mesh fixation will be used.
|
| Active Comparator: absorbable fixation right side |
Device: permanent mesh fixation
Permanent mesh fixation will be used.
Device: absorbable mesh fixation
Absorbable mesh fixation will be used.
|
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 adult patient (18 years and older, no maximum age)
- primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair
Exclusion Criteria:
- no written informed consent
- hernia defects larger than 10cm diameter in width
- 'hostile' abdomen; open abdomen treatment
- contraindication to pneumoperitoneum
- emergency surgery (incarcerated hernia)
- lateral or parastomal hernia sites
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109771
Contacts
| Contact: Frederik Berrevoet, MD | frederik.berrevoet@ugent.be |
Locations
| Belgium | |
| Virga Jesseziekenhuis | Recruiting |
| Hasselt, Limburg, Belgium, 3500 | |
| Principal Investigator: Dr. B. Appeltans | |
| Imelda Ziekenhuis | Recruiting |
| Bonheiden, Belgium | |
| Principal Investigator: T. Tollens, MD | |
| CHU Charleroi | Recruiting |
| Charleroi, Belgium | |
| Principal Investigator: Dr. Pitot | |
| St-Vincentius Ziekenhuis | Recruiting |
| Deinze, Belgium | |
| Principal Investigator: L. Berwouts, MD | |
| AZ Sint-Dymphna | Recruiting |
| Geel, Belgium | |
| Principal Investigator: T. Lafullarde, MD | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium | |
| Principal Investigator: Frederik Berrevoet, MD | |
| Ziekenhuis Maas en Kempen | Recruiting |
| Maaseik, Belgium | |
| Principal Investigator: S. Bessemans, MD | |
| AZ Sint-Maarten | Recruiting |
| Mechelen, Belgium | |
| Principal Investigator: J. Ceulemans, MD | |
| Heilig Hart Ziekenhuis | Recruiting |
| Mol, Belgium | |
| Principal Investigator: I. Jacobs, MD | |
| UCL Mont-Godinne | Recruiting |
| Mont-Godinne, Belgium | |
| Principal Investigator: Dr. V. De Moor | |
| H. Serruys Ziekenhuis | Recruiting |
| Oostende, Belgium | |
| Principal Investigator: L. Deruyter, MD | |
Sponsors and Collaborators
University Hospital, Ghent
Covidien
Investigators
| Principal Investigator: | Frederik Berrevoet, MD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01109771 History of Changes |
| Other Study ID Numbers: | 2008/702 |
| Study First Received: | April 22, 2010 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Ghent:
|
Ventral hernia |
Additional relevant MeSH terms:
|
Hernia Hernia, Ventral Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on June 17, 2013