Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair
NCT ID: NCT00773851
Last Updated: 2023-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2005-04-30
2008-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
transfacial sutures
mesh fixation by transfacial sutures
mesh fixation by transfacial sutures
B
staples
mesh fixation by staples
mesh fixation by staples
Interventions
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mesh fixation by transfacial sutures
mesh fixation by transfacial sutures
mesh fixation by staples
mesh fixation by staples
Eligibility Criteria
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Inclusion Criteria
* obtained informed consent
Exclusion Criteria
* Residual intraperitoneal mesh
* contaminated abdominal cavity
* longterm use of corticosteroids and other immunosuppressive agents
* bodymass index \> 45
* general contradictions for laparoscopy
18 Years
ALL
No
Sponsors
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Sofradim Production
INDUSTRY
Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Guido1 Beldi, MD
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital
Locations
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Dep. of Visceral and Transplantsurgery, Bern University Hospital
Bern, , Switzerland
Countries
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References
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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.
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.
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.
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.
LeBlanc KA. The critical technical aspects of laparoscopic repair of ventral and incisional hernias. Am Surg. 2001 Aug;67(8):809-12.
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.
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.
LeBlanc KA. Tack hernia: a new entity. JSLS. 2003 Oct-Dec;7(4):383-7.
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.
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.
Other Identifiers
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KEK_11/05
Identifier Type: -
Identifier Source: org_study_id
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