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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01109771
First received: April 22, 2010
Last updated: December 4, 2014
Last verified: December 2014
  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 2015
Estimated Primary Completion Date: August 2015 (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   (Adult, Senior)
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

Locations
Belgium
Virga Jesseziekenhuis
Hasselt, Limburg, Belgium, 3500
Imelda Ziekenhuis
Bonheiden, Belgium
CHU Charleroi
Charleroi, Belgium
St-Vincentius Ziekenhuis
Deinze, Belgium
AZ Sint-Dymphna
Geel, Belgium
University Hospital Ghent
Ghent, Belgium
Ziekenhuis Maas en Kempen
Maaseik, Belgium
AZ Sint-Maarten
Mechelen, Belgium
Heilig Hart Ziekenhuis
Mol, Belgium
UCL Mont-Godinne
Mont-Godinne, Belgium
H. Serruys Ziekenhuis
Oostende, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Medtronic - MITG
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
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: December 4, 2014
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 December 05, 2016