Clinical Trials Directory

Trials / Completed

CompletedNCT00773851

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

Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Medtronic - MITG · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREmesh fixation by transfacial suturesmesh fixation by transfacial sutures
PROCEDUREmesh fixation by staplesmesh fixation by staples

Timeline

Start date
2005-04-01
Primary completion
2008-02-01
Completion
2008-10-01
First posted
2008-10-16
Last updated
2023-11-02

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT00773851. Inclusion in this directory is not an endorsement.