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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | mesh fixation by transfacial sutures | mesh fixation by transfacial sutures |
| PROCEDURE | mesh fixation by staples | mesh 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.