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:
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
  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:


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 April 17, 2014