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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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absorbable fixation left side

Group Type ACTIVE_COMPARATOR

permanent mesh fixation

Intervention Type DEVICE

Permanent mesh fixation will be used.

absorbable mesh fixation

Intervention Type DEVICE

Absorbable mesh fixation will be used.

absorbable fixation right side

Group Type ACTIVE_COMPARATOR

permanent mesh fixation

Intervention Type DEVICE

Permanent mesh fixation will be used.

absorbable mesh fixation

Intervention Type DEVICE

Absorbable mesh fixation will be used.

Interventions

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permanent mesh fixation

Permanent mesh fixation will be used.

Intervention Type DEVICE

absorbable mesh fixation

Absorbable mesh fixation will be used.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No