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

Not Applicable

Completed

• Conditions: Ventral Hernia
• Interventions: Device: permanent mesh fixation; Device: absorbable mesh fixation

• Registration Number: NCT01109771
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Primary Completion: 2015-08
• Study Completion: 2015-08-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
absorbable fixation right side	permanent mesh fixation	-
absorbable fixation left side	permanent mesh fixation	-
absorbable fixation left side	absorbable mesh fixation	-
absorbable fixation right side	absorbable mesh fixation	-

Primary Outcome Measures

Name	Time	Method
number of patients with a VAS scale more than 40	1 year after surgery	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).

Secondary Outcome Measures

Name	Time	Method
perioperative morbidity rate	1 year after surgery	perioperative morbidity rate, 1 year after surgery
number of invasive interventions (local infiltrations, reoperations) postoperatively	1 year after surgery	number of invasive interventions (local infiltrations, reoperations) postoperatively, 1 year after surgery
number of patients taking analgetics using MCGill painscore	1 year post-surgery	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.
quality of life by using EQ5D score	1 year post-surgery	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.
recurrence rate	1 year post-surgery	recurrence rate, 1 year post-surgery

Trial Locations

Locations (11)

AZ Sint-Dymphna; 🇧🇪 Geel, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Ziekenhuis Maas en Kempen; 🇧🇪 Maaseik, Belgium

UCL Mont-Godinne; 🇧🇪 Namur, Belgium

Heilig Hart Ziekenhuis; 🇧🇪 Mol, Belgium

H. Serruys Ziekenhuis; 🇧🇪 Oostende, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

CHU Charleroi; 🇧🇪 Charleroi, Belgium

AZ Sint-Maarten; 🇧🇪 Mechelen, Belgium

Virga Jesseziekenhuis; 🇧🇪 Hasselt, Limburg, Belgium

St-Vincentius Ziekenhuis; 🇧🇪 Deinze, Belgium