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OpenTrials
Completed

NCT Number: NCT00773851

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

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.

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Key information

Conditions

Ventral Hernia Disease Attributes Hernia Hernia, Abdominal Hernia, Ventral Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Visceral and Transplantsurgery, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mesh fixation by transfacial sutures

Procedure

mesh fixation by transfacial sutures

mesh fixation by staples

Procedure

mesh fixation by staples

Primary outcomes

  1. mesh shrinkage

    Time frame: perioperative, 6 weeks, 6 months postoperative

Secondary outcomes

  1. mesh dislocation

    Time frame: perioperative, 6 weeks postoperative,6 months postoperative

  2. pain

    Time frame: perioperative, 6 weeks postoperative,6 months, 12 moths postoperative

  3. recurrence

    Time frame: perioperative, 6 weeks postoperative,6 months, 12 months postoperative

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Collaborators

  • Sofradim Production

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 16, 2008
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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