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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: permanent mesh fixation; Device: absorbable mesh fixation

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Frederik Berrevoet, MD; Email: frederik.berrevoet@ugent.be

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Imelda Ziekenhuis
  • Charleroi, Belgium
    • Chu Charleroi
  • Deinze, Belgium
    • St-Vincentius Ziekenhuis
  • Geel, Belgium
    • AZ Sint-Dymphna
  • Ghent, Belgium
    • University Hospital Ghent
  • Maaseik, Belgium
    • Ziekenhuis Maas en Kempen
  • Mechelen, Belgium
    • Az Sint-Maarten
  • Mol, Belgium
    • Heilig Hart Ziekenhuis
  • Mont-Godinne, Belgium
    • UCL Mont-Godinne
  • Oostende, Belgium
    • H. Serruys Ziekenhuis
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Virga Jesseziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of patients with a VAS scale more than 40	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
number of invasive interventions (local infiltrations, reoperations) postoperatively	1 year after surgery
number of patients taking analgetics	1 year post-surgery
perioperative morbidity rate	1 year after surgery
quality of life	1 year post-surgery
recurrence rate	1 year post-surgery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: Frederik Berrevoet, MD, University Hospital, Ghent

Publications and helpful links

Helpful Links

• website University Hospital Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 31, 2015

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimated): April 23, 2010

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ventral hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 2008/702

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No