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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: absorbable mesh fixation; Device: permanent mesh fixation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01109771

2008/702

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

absorbable fixation left side

Active Comparator group

Treatment:

Device: absorbable mesh fixation

Device: permanent mesh fixation

absorbable fixation right side

Active Comparator group

Treatment:

Device: absorbable mesh fixation

Device: permanent mesh fixation