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

This study has been completed.
Sponsor:
Collaborator:
Sofradim Production
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00773851
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Ventral Hernia
Pain
Procedure: mesh fixation by transfacial sutures
Procedure: mesh fixation by staples

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • mesh shrinkage [ Time Frame: perioperative, 6 weeks, 6 months postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mesh dislocation [ Time Frame: perioperative, 6 weeks postoperative,6 months postoperative ] [ Designated as safety issue: Yes ]
  • pain [ Time Frame: perioperative, 6 weeks postoperative,6 months, 12 moths postoperative ] [ Designated as safety issue: No ]
  • recurrence [ Time Frame: perioperative, 6 weeks postoperative,6 months, 12 months postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: April 2005
Study Completion Date: October 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
transfacial sutures
Procedure: mesh fixation by transfacial sutures
mesh fixation by transfacial sutures
B
staples
Procedure: mesh fixation by staples
mesh fixation by staples

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00773851

Locations
Switzerland
Dep. of Visceral and Transplantsurgery, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Sofradim Production
Investigators
Principal Investigator: Guido1 Beldi, MD Bern University Hospital
  More Information

Publications:

Responsible Party: Guido Beldi, MD, Dep. of Visceral and Transplantsurgery, Bern University Hospital
ClinicalTrials.gov Identifier: NCT00773851     History of Changes
Other Study ID Numbers: KEK_11/05
Study First Received: October 15, 2008
Last Updated: October 15, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
ventral hernia
laparoscopy
mesh
recurrence

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 22, 2014