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

NCT00773851 | Completed

• 1 other identifier: KEK_11/05
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia; Pain

Keywords

ventral hernia; laparoscopy; mesh; recurrence

Outcome Measures

Primary Outcomes (1)

• mesh shrinkage

  perioperative, 6 weeks, 6 months postoperative

Secondary Outcomes (3)

• mesh dislocation

  perioperative, 6 weeks postoperative,6 months postoperative

• pain

  perioperative, 6 weeks postoperative,6 months, 12 moths postoperative

• recurrence

  perioperative, 6 weeks postoperative,6 months, 12 months postoperative

Study Arms (2)

A

OTHER

transfacial sutures

Procedure: mesh fixation by transfacial sutures

B

OTHER

staples

Procedure: mesh fixation by staples

Interventions

mesh fixation by transfacial sutures PROCEDURE

mesh fixation by transfacial sutures

A

mesh fixation by staples PROCEDURE

mesh fixation by staples

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with incisional hernia smaller than 8cm in diameter
• obtained informed consent

You may not qualify if:

• Pregnancy
• Residual intraperitoneal mesh
• contaminated abdominal cavity
• longterm use of corticosteroids and other immunosuppressive agents
• bodymass index \> 45
• general contradictions for laparoscopy

Sponsors & Collaborators

• Medtronic - MITG: lead
• Sofradim Production: collaborator

Study Sites (1)

Dep. of Visceral and Transplantsurgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (10)

• 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.

  PMID: 14501505 BACKGROUND

• 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.

  PMID: 14634842 BACKGROUND

• 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.

  PMID: 12098028 BACKGROUND

• 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.

  PMID: 14752650 BACKGROUND

• LeBlanc KA. The critical technical aspects of laparoscopic repair of ventral and incisional hernias. Am Surg. 2001 Aug;67(8):809-12.

  PMID: 11510590 BACKGROUND

• 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.

  PMID: 12399849 BACKGROUND

• 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.

  PMID: 12811619 BACKGROUND

• LeBlanc KA. Tack hernia: a new entity. JSLS. 2003 Oct-Dec;7(4):383-7.

  PMID: 14626408 BACKGROUND

• 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.

  PMID: 9565117 BACKGROUND

• 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.

  PMID: 14648721 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral; Pain; Recurrence

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Guido1 Beldi, MD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: April 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 2, 2023

Record last verified: 2023-11

Locations

CH (1)