Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic - MITG
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- mesh shrinkage
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
transfacial sutures
Intervention: mesh fixation by transfacial sutures (Procedure)
B
staples
Intervention: mesh fixation by staples (Procedure)
Outcomes
Primary Outcomes
mesh shrinkage
Time Frame: perioperative, 6 weeks, 6 months postoperative
Secondary Outcomes
- 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)