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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00773851

Enrollment

Registered

2008-10-16

Start date

2005-04-30

Completion date

2008-10-31

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Ventral Hernia

Keywords

ventral hernia, laparoscopy, mesh, recurrence

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.

Interventions

PROCEDUREmesh fixation by staples

mesh fixation by staples

PROCEDUREmesh fixation by transfacial sutures

mesh fixation by transfacial sutures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
mesh shrinkage	perioperative, 6 weeks, 6 months postoperative

Secondary

Measure	Time frame
mesh dislocation	perioperative, 6 weeks postoperative,6 months postoperative
pain	perioperative, 6 weeks postoperative,6 months, 12 moths postoperative
recurrence	perioperative, 6 weeks postoperative,6 months, 12 months postoperative

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026