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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773851
First Posted: October 16, 2008
Last Update Posted: April 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sofradim Production
Information provided by (Responsible Party):
Medtronic - MITG
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Medtronic - MITG:

Primary Outcome Measures:
  • mesh shrinkage [ Time Frame: perioperative, 6 weeks, 6 months postoperative ]

Secondary Outcome Measures:
  • mesh dislocation [ Time Frame: perioperative, 6 weeks postoperative,6 months postoperative ]
  • pain [ Time Frame: perioperative, 6 weeks postoperative,6 months, 12 moths postoperative ]
  • recurrence [ Time Frame: perioperative, 6 weeks postoperative,6 months, 12 months postoperative ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773851


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

Publications:

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00773851     History of Changes
Other Study ID Numbers: KEK_11/05
First Submitted: October 15, 2008
First Posted: October 16, 2008
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by Medtronic - MITG:
ventral hernia
laparoscopy
mesh
recurrence

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