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

University Hospital, Ghent105 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

105

Conditions

Ventral Hernia

Interventions

permanent mesh fixationDEVICE

Permanent mesh fixation will be used.

absorbable mesh fixationDEVICE

Absorbable mesh fixation will be used.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Virga Jesseziekenhuis

Hasselt, Limburg, Belgium

Imelda Ziekenhuis

Bonheiden, Belgium

CHU Charleroi

Charleroi, Belgium

St-Vincentius Ziekenhuis

Deinze, Belgium

Outcomes

Primary Outcomes

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).

Time frame: 1 year after surgery

Secondary Outcomes

number of invasive interventions (local infiltrations, reoperations) postoperatively

number of invasive interventions (local infiltrations, reoperations) postoperatively, 1 year after surgery

Time frame: 1 year after 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.

Time frame: 1 year post-surgery

perioperative morbidity rate

perioperative morbidity rate, 1 year after surgery

Data from ClinicalTrials.gov

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