Stapler Versus Glue for Laparoscopic Groin Hernia Repair

NCT00793286 | Completed

• 1 other identifier: KEK_89_04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Repair of inguinal hernia is the most common operation of the general surgeon. In recent years, it was recognized that chronic postoperative pain is as important for postoperative outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated patients. Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.

Conditions

Inguinal Hernia; Recurrence; Pain

Keywords

inguinal hernia; laparoscopy; mesh

Outcome Measures

Primary Outcomes (1)

• Recurrence

  6 weeks, 6 months, 12 months postoperative

Secondary Outcomes (3)

• postoperative pain

  6 weeks, 6 months, 12 months postoperative

• sensibility disorder

  6 weeks, 6 months, 12 months postoperative

• intra- and postoperative complications

  6 weeks, 6 months, 12 months postoperative

Study Arms (2)

A

OTHER

Mesh fixation by staples

Procedure: Mesh fixation by staples

B

OTHER

Mesh fixation by glue

Procedure: Mesh fixation by glue

Interventions

Mesh fixation by staples PROCEDURE

Mesh fixation by staples

A

Mesh fixation by glue PROCEDURE

Mesh fixation by glue

Also known as: N-Butyl-2 Cyanoacrulat Glue

B

Eligibility Criteria

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

You may qualify if:

• patients scheduled for laparoscopic primary inguinal hernia repair
• uni- or bilateral patients with recurrent hernias after anterior surgical technique
• written informed consent

You may not qualify if:

• general contradictions for laparoscopy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Visceral and Transplantsurgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (8)

• McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;2003(1):CD001785. doi: 10.1002/14651858.CD001785.

  PMID: 12535413 BACKGROUND

• Cunningham J, Temple WJ, Mitchell P, Nixon JA, Preshaw RM, Hagen NA. Cooperative hernia study. Pain in the postrepair patient. Ann Surg. 1996 Nov;224(5):598-602. doi: 10.1097/00000658-199611000-00003.

  PMID: 8916874 BACKGROUND

• Bay-Nielsen M, Perkins FM, Kehlet H; Danish Hernia Database. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg. 2001 Jan;233(1):1-7. doi: 10.1097/00000658-200101000-00001.

  PMID: 11141218 BACKGROUND

• Laparoscopic versus open repair of groin hernia: a randomised comparison. The MRC Laparoscopic Groin Hernia Trial Group. Lancet. 1999 Jul 17;354(9174):185-90.

  PMID: 10421299 BACKGROUND

• Katkhouda N, Mavor E, Friedlander MH, Mason RJ, Kiyabu M, Grant SW, Achanta K, Kirkman EL, Narayanan K, Essani R. Use of fibrin sealant for prosthetic mesh fixation in laparoscopic extraperitoneal inguinal hernia repair. Ann Surg. 2001 Jan;233(1):18-25. doi: 10.1097/00000658-200101000-00004.

  PMID: 11141220 BACKGROUND

• Jourdan IC, Bailey ME. Initial experience with the use of N-butyl 2-cyanoacrylate glue for the fixation of polypropylene mesh in laparoscopic hernia repair. Surg Laparosc Endosc. 1998 Aug;8(4):291-3.

  PMID: 9703604 BACKGROUND

• Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.

  PMID: 15107485 BACKGROUND

• Bittner R, Schmedt CG, Schwarz J, Kraft K, Leibl BJ. Laparoscopic transperitoneal procedure for routine repair of groin hernia. Br J Surg. 2002 Aug;89(8):1062-6. doi: 10.1046/j.1365-2168.2002.02178.x.

  PMID: 12153636 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Recurrence; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Guido Beldi, MD

  Dep. of Visceral and Transplantsurgery, 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: OTHER

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: August 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 24, 2008

Record last verified: 2008-11

Locations

CH (1)