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

Primary Purpose

Ventral Hernia, Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
mesh fixation by transfacial sutures
mesh fixation by staples
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring ventral hernia, laparoscopy, mesh, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dep. of Visceral and Transplantsurgery, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

transfacial sutures

staples

Outcomes

Primary Outcome Measures

mesh shrinkage

Secondary Outcome Measures

mesh dislocation
pain
recurrence

Full Information

First Posted
October 15, 2008
Last Updated
April 21, 2016
Sponsor
Medtronic - MITG
Collaborators
Sofradim Production
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1. Study Identification

Unique Protocol Identification Number
NCT00773851
Brief Title
Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair
Official Title
Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
Collaborators
Sofradim Production

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Pain
Keywords
ventral hernia, laparoscopy, mesh, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
transfacial sutures
Arm Title
B
Arm Type
Other
Arm Description
staples
Intervention Type
Procedure
Intervention Name(s)
mesh fixation by transfacial sutures
Intervention Description
mesh fixation by transfacial sutures
Intervention Type
Procedure
Intervention Name(s)
mesh fixation by staples
Intervention Description
mesh fixation by staples
Primary Outcome Measure Information:
Title
mesh shrinkage
Time Frame
perioperative, 6 weeks, 6 months postoperative
Secondary Outcome Measure Information:
Title
mesh dislocation
Time Frame
perioperative, 6 weeks postoperative,6 months postoperative
Title
pain
Time Frame
perioperative, 6 weeks postoperative,6 months, 12 moths postoperative
Title
recurrence
Time Frame
perioperative, 6 weeks postoperative,6 months, 12 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido1 Beldi, MD
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Visceral and Transplantsurgery, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
14501505
Citation
Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.
Results Reference
background
PubMed Identifier
14634842
Citation
Borrazzo EC, Belmont MF, Boffa D, Fowler DL. Effect of prosthetic material on adhesion formation after laparoscopic ventral hernia repair in a porcine model. Hernia. 2004 May;8(2):108-12. doi: 10.1007/s10029-003-0181-6. Epub 2003 Nov 21.
Results Reference
background
PubMed Identifier
12098028
Citation
van't Riet M, de Vos van Steenwijk PJ, Kleinrensink GJ, Steyerberg EW, Bonjer HJ. Tensile strength of mesh fixation methods in laparoscopic incisional hernia repair. Surg Endosc. 2002 Dec;16(12):1713-6. doi: 10.1007/s00464-001-9202-7. Epub 2002 Jul 8.
Results Reference
background
PubMed Identifier
14752650
Citation
Winslow ER, Diaz S, Desai K, Meininger T, Soper NJ, Klingensmith ME. Laparoscopic incisional hernia repair in a porcine model: what do transfixion sutures add? Surg Endosc. 2004 Mar;18(3):529-35. doi: 10.1007/s00464-003-8519-9. Epub 2004 Feb 2.
Results Reference
background
PubMed Identifier
11510590
Citation
LeBlanc KA. The critical technical aspects of laparoscopic repair of ventral and incisional hernias. Am Surg. 2001 Aug;67(8):809-12.
Results Reference
background
PubMed Identifier
12399849
Citation
Carbajo MA, Martp del Olmo JC, Blanco JI, Toledano M, de la Cuesta C, Ferreras C, Vaquero C. Laparoscopic approach to incisional hernia. Surg Endosc. 2003 Jan;17(1):118-22. doi: 10.1007/s00464-002-9079-0. Epub 2002 Oct 29.
Results Reference
background
PubMed Identifier
12811619
Citation
Chelala E, Gaede F, Douillez V, Dessily M, Alle JL. The suturing concept for laparoscopic mesh fixation in ventral and incisional hernias: preliminary results. Hernia. 2003 Dec;7(4):191-6. doi: 10.1007/s10029-003-0143-z. Epub 2003 Jun 13.
Results Reference
background
PubMed Identifier
14626408
Citation
LeBlanc KA. Tack hernia: a new entity. JSLS. 2003 Oct-Dec;7(4):383-7.
Results Reference
background
PubMed Identifier
9565117
Citation
Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg. 1998 Apr;133(4):378-82. doi: 10.1001/archsurg.133.4.378.
Results Reference
background
PubMed Identifier
14648721
Citation
Schumpelick V, Klinge U. Prosthetic implants for hernia repair. Br J Surg. 2003 Dec;90(12):1457-8. doi: 10.1002/bjs.4385. No abstract available.
Results Reference
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Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair

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