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

April 22, 2010
February 1, 2013
April 2010
August 2013   (final data collection date for primary outcome measure)
number of patients with a VAS scale more than 40 [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01109771 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Ventral Hernia
  • Device: permanent mesh fixation
    Permanent mesh fixation will be used.
  • Device: absorbable mesh fixation
    Absorbable mesh fixation will be used.
  • Active Comparator: absorbable fixation left side
    Interventions:
    • Device: permanent mesh fixation
    • Device: absorbable mesh fixation
  • Active Comparator: absorbable fixation right side
    Interventions:
    • Device: permanent mesh fixation
    • Device: absorbable mesh fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
August 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Frederik Berrevoet, MD frederik.berrevoet@ugent.be
Belgium
 
NCT01109771
2008/702
No
University Hospital, Ghent
University Hospital, Ghent
Covidien
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP