Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair

Not Applicable

Completed

• Conditions: Pain; Ventral Hernia
• Interventions: Procedure: mesh fixation by transfacial sutures; Procedure: mesh fixation by staples

• Registration Number: NCT00773851
• Lead Sponsor: Medtronic - MITG

Brief Summary

Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means. Different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.

Detailed Description

Ventral hernia repair is increasingly performed by laparoscopic means. While mesh ingrowth and shrink-age has been analysed in the experimental setting, there is scarce data available in humans. In addition, different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients.

Mesh shrinkage is assessed using two different techniques for fixation.

Blinded randomized trial using a Parietene composite mesh for laparoscopic ventral hernia repair. Patients with ventral hernias of no larger than 8 cm were assigned to either mesh fixation using transfacial nonabsorbable sutures or titan tacks. Primary endpoint was mesh migration, secondary endpoints were mesh shrinkage, surgical morbidity and pain.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2008-02
• Study Completion: 2008-10
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients with incisional hernia smaller than 8cm in diameter
• obtained informed consent

Exclusion Criteria

• Pregnancy
• Residual intraperitoneal mesh
• contaminated abdominal cavity
• longterm use of corticosteroids and other immunosuppressive agents
• bodymass index > 45
• general contradictions for laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	mesh fixation by transfacial sutures	transfacial sutures
B	mesh fixation by staples	staples

Primary Outcome Measures

Name	Time	Method
mesh shrinkage	perioperative, 6 weeks, 6 months postoperative

Secondary Outcome Measures

Name	Time	Method
recurrence	perioperative, 6 weeks postoperative,6 months, 12 months postoperative
mesh dislocation	perioperative, 6 weeks postoperative,6 months postoperative
pain	perioperative, 6 weeks postoperative,6 months, 12 moths postoperative

Trial Locations

Locations (1)

Dep. of Visceral and Transplantsurgery, Bern University Hospital; 🇨🇭 Bern, Switzerland