Skip to main content
OpenTrials
Completed

NCT Number: NCT01109771

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virga Jesseziekenhuis, Hasselt, Limburg, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

permanent mesh fixation

Device

Permanent mesh fixation will be used.

absorbable mesh fixation

Device

Absorbable mesh fixation will be used.

Primary outcomes

  1. number of patients with a VAS scale more than 40

    Time frame: 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 outcomes

  1. number of invasive interventions (local infiltrations, reoperations) postoperatively

    Time frame: 1 year after surgery

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

  2. number of patients taking analgetics using MCGill painscore

    Time frame: 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.

  3. perioperative morbidity rate

    Time frame: 1 year after surgery

    perioperative morbidity rate, 1 year after surgery

  4. quality of life by using EQ5D score

    Time frame: 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.

  5. recurrence rate

    Time frame: 1 year post-surgery

    recurrence rate, 1 year post-surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

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

Acronym: SORBET

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2010
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.