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

Primary Purpose

Ventral Hernia

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
permanent mesh fixation
absorbable mesh fixation
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring Ventral hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virga Jesseziekenhuis
  • Imelda Ziekenhuis
  • CHU Charleroi
  • St-Vincentius Ziekenhuis
  • AZ Sint-Dymphna
  • University Hospital Ghent
  • Ziekenhuis Maas en Kempen
  • AZ Sint-Maarten
  • Heilig Hart Ziekenhuis
  • UCL Mont-Godinne
  • H. Serruys Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

absorbable fixation left side

absorbable fixation right side

Arm Description

Outcomes

Primary Outcome Measures

number of patients with a VAS scale more than 40

Secondary Outcome Measures

number of invasive interventions (local infiltrations, reoperations) postoperatively
number of patients taking analgetics
perioperative morbidity rate
quality of life
recurrence rate

Full Information

First Posted
April 22, 2010
Last Updated
August 31, 2023
Sponsor
University Hospital, Ghent
Collaborators
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT01109771
Brief Title
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair
Acronym
SORBET
Official Title
Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
Ventral hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
absorbable fixation left side
Arm Type
Active Comparator
Arm Title
absorbable fixation right side
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
permanent mesh fixation
Intervention Description
Permanent mesh fixation will be used.
Intervention Type
Device
Intervention Name(s)
absorbable mesh fixation
Intervention Description
Absorbable mesh fixation will be used.
Primary Outcome Measure Information:
Title
number of patients with a VAS scale more than 40
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
number of invasive interventions (local infiltrations, reoperations) postoperatively
Time Frame
1 year after surgery
Title
number of patients taking analgetics
Time Frame
1 year post-surgery
Title
perioperative morbidity rate
Time Frame
1 year after surgery
Title
quality of life
Time Frame
1 year post-surgery
Title
recurrence rate
Time Frame
1 year post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virga Jesseziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
CHU Charleroi
City
Charleroi
Country
Belgium
Facility Name
St-Vincentius Ziekenhuis
City
Deinze
Country
Belgium
Facility Name
AZ Sint-Dymphna
City
Geel
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
Facility Name
Ziekenhuis Maas en Kempen
City
Maaseik
Country
Belgium
Facility Name
AZ Sint-Maarten
City
Mechelen
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis
City
Mol
Country
Belgium
Facility Name
UCL Mont-Godinne
City
Mont-Godinne
Country
Belgium
Facility Name
H. Serruys Ziekenhuis
City
Oostende
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent

Learn more about this trial

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

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