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: Not Applicable

Contacts and Locations

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
  • Namur, 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	Measure Description	Time Frame
number of patients with a VAS scale more than 40	The Visual Analogue Scale (VAS) is commonly used to measure the intensity of pain or other subjective experiences. It is a simple and effective tool. The VAS consists of a straight line, usually 10 cm long, with endpoints defining extreme limits such as 'No pain' and 'Worst imaginable pain'. Respondents mark a point on the line that represents their perception of their current state. Scoring: Scale Title: Visual Analogue Scale (VAS) Minimum Value: 0 (indicating no pain or the least possible experience of the measured parameter) Maximum Value: 10 (indicating worst imaginable pain or the most extreme experience of the measured parameter) Higher Scores: Indicate a worse outcome (e.g., more intense pain or greater severity of the measured parameter).	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of invasive interventions (local infiltrations, reoperations) postoperatively	number of invasive interventions (local infiltrations, reoperations) postoperatively, 1 year after surgery	1 year after surgery
perioperative morbidity rate	perioperative morbidity rate, 1 year after surgery	1 year after surgery
recurrence rate	recurrence rate, 1 year post-surgery	1 year post-surgery
number of patients taking analgetics using MCGill painscore	The McGill Pain Questionnaire (MPQ) measures the quality and intensity of pain through three components: Pain Rating Index (PRI): Derived from 78 pain descriptors in four categories: Sensory (S), Affective (A), Evaluative (E), Miscellaneous (M). Each descriptor has a numerical value. Scale Title: Pain Rating Index (PRI) Range: 0-78 Higher Scores: Indicate greater intensity of pain. Present Pain Intensity (PPI): A single-item scale rating current pain on a 6-point scale. Scale Title: Present Pain Intensity (PPI) Range: 0 (No Pain) to 5 (Excruciating Pain) Higher Scores: Indicate greater intensity of pain. Number of Words Chosen (NWC): Total pain descriptors selected. Scale Title: Number of Words Chosen (NWC) Range: 0-20 Higher Scores: Indicate more complex or severe pain.	1 year post-surgery
quality of life by using EQ5D score	The EQ-5D is a standardized instrument for measuring generic health status, providing a descriptive profile and a single index value. Descriptive System: Comprises five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension has three severity levels: No problems, Some problems, Extreme problems. Responses form a five-digit number describing the health state (e.g., 11223). EQ Visual Analogue Scale (EQ VAS): Records self-rated health on a vertical scale from 0 (Worst health) to 100 (Best health), quantifying the patient's overall health perception. EQ-5D Index Value: Derived from the descriptive system. Scale Title: EQ-5D Index Value Range: Typically -0.594 to 1 Higher Scores: Indicate better health outcomes.	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): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

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