NCT01109771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

5.3 years

First QC Date

April 22, 2010

Last Update Submit

July 4, 2024

Conditions

Ventral Hernia

Keywords

Ventral hernia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • number of invasive interventions (local infiltrations, reoperations) postoperatively

    1 year after surgery

  • number of patients taking analgetics using MCGill painscore

    1 year post-surgery

  • perioperative morbidity rate

    1 year after surgery

  • quality of life by using EQ5D score

    1 year post-surgery

  • recurrence rate

    1 year post-surgery

Study Arms (2)

absorbable fixation left side

ACTIVE COMPARATOR
Device: permanent mesh fixationDevice: absorbable mesh fixation

absorbable fixation right side

ACTIVE COMPARATOR
Device: permanent mesh fixationDevice: absorbable mesh fixation

Interventions

permanent mesh fixationDEVICE

Permanent mesh fixation will be used.

absorbable fixation left sideabsorbable fixation right side
absorbable mesh fixationDEVICE

Absorbable mesh fixation will be used.

absorbable fixation left sideabsorbable fixation right side

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Virga Jesseziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

St-Vincentius Ziekenhuis

Deinze, Belgium

Location

AZ Sint-Dymphna

Geel, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

Ziekenhuis Maas en Kempen

Maaseik, Belgium

Location

AZ Sint-Maarten

Mechelen, Belgium

Location

Heilig Hart Ziekenhuis

Mol, Belgium

Location

UCL Mont-Godinne

Namur, Belgium

Location

H. Serruys Ziekenhuis

Ostend, Belgium

Location

Related Links

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Berrevoet, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 23, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2015

Study Completion

August 31, 2015

Last Updated

July 8, 2024

Record last verified: 2024-07

Locations

BE(11)