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

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Medtronic

Status

Completed

Conditions

Ventral Hernia
Pain

Treatments

Procedure: mesh fixation by transfacial sutures
Procedure: mesh fixation by staples

Study type

Interventional

Funder types

Industry

Identifiers

NCT00773851
KEK_11/05

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

A
Other group
Description:
transfacial sutures
Treatment:
Procedure: mesh fixation by transfacial sutures
B
Other group
Description:
staples
Treatment:
Procedure: mesh fixation by staples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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