Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014