Clinical trial NCT00773851: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Pain
Keywords: ventral hernia
laparoscopy
mesh
recurrence
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Sofradim Production
First posted: 2008-10-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: mesh shrinkage
timeFrame: perioperative, 6 weeks, 6 months postoperative
Secondary outcomes:
measure: mesh dislocation
timeFrame: perioperative, 6 weeks postoperative,6 months postoperative
measure: pain
timeFrame: perioperative, 6 weeks postoperative,6 months, 12 moths postoperative
measure: recurrence
timeFrame: perioperative, 6 weeks postoperative,6 months, 12 months postoperative
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Visceral and Transplantsurgery, Bern University Hospital
Study officials:
affiliation: Bern University Hospital
name: Guido1 Beldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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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.
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.
citation: LeBlanc KA. Tack hernia: a new entity. JSLS. 2003 Oct-Dec;7(4):383-7.
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.
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.