Stapler Versus Glue for Laparoscopic Groin Hernia Repair - Full Text View

Purpose

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.

Condition	Intervention
Inguinal Hernia Recurrence Pain	Procedure: Mesh fixation by staples Procedure: Mesh fixation by glue

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Stapler Versus Glue for Laparoscopic Groin Hernia Repair

Resource links provided by NLM:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Recurrence [ Time Frame: 6 weeks, 6 months, 12 months postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

postoperative pain [ Time Frame: 6 weeks, 6 months, 12 months postoperative ] [ Designated as safety issue: No ]
sensibility disorder [ Time Frame: 6 weeks, 6 months, 12 months postoperative ] [ Designated as safety issue: No ]
intra- and postoperative complications [ Time Frame: 6 weeks, 6 months, 12 months postoperative ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	August 2004
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Mesh fixation by staples	Procedure: Mesh fixation by staples Mesh fixation by staples
B Mesh fixation by glue	Procedure: Mesh fixation by glue Mesh fixation by glue Other Name: N-Butyl-2 Cyanoacrulat Glue

Detailed Description:

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.

To perform a prospective randomized trial comparing pain after inguinal hernia repair using either fixation with stapler or histoacryl.

The standard TAPP procedure is performed under general anesthesia. Patients receive a single shot antibiotic prophylaxis, using Amoxicillin/Clavulanic Acids. Operations are performed by resident surgeons under supervision, consultants or senior consultants. After hernial sac dissection and retraction, preperitoneal fat is removed bluntly and Cooper's ligament is identified. A Vypro II ® (Ethicon ®) prosthetic mesh, 10x15 cm, is placed and fixed depending on randomization with either 5 mm Protack TM (Autosuture TM) or Glubran ® 2 (G.E.M., Viareggio, Italy). Randomization is performed in permutated block of 20 using sealed envelopes. Where tissue glue is used, meshs are additionally fixed caudally and laterocaudally. Peritoneal closure over the mesh is performed using resorptive sutures. Glubran ® 2 is a cyanoacrylate tissue adhesive. Follow up assessment: The use of analgesics in the postoperative period is standardized using paracetamol and morphine derivates. Following discharge patients are liberated of physical restrictions. Patient follow-up will be performed after 6 weeks, 6 and 12 months postoperatively. Patients are advised to mention pain in the operated groin area. In addition the Visual Analogue Scale is used to evaluate pain intensity.Statistical comparison is done using Mann-Whitney Test and Chi square Test (significance p < 0,05).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

general contradictions for laparoscopy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793286

Locations

Switzerland
Dep. of Visceral and Transplantsurgery, Bern University Hospital
Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator:

Guido Beldi, MD

Dep. of Visceral and Transplantsurgery, Bern University Hospital

More Information

Publications:

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;(1):CD001785. Review.

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.

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.

[No authors listed] 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.

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.

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.

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. Epub 2004 Apr 25.

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.

Responsible Party:	Guido Beldi, MD, Dep. of Visceral and Transplantsurgery, Bern University Hospital
ClinicalTrials.gov Identifier:	NCT00793286 History of Changes
Other Study ID Numbers:	KEK_89_04
Study First Received:	November 18, 2008
Last Updated:	November 21, 2008
Health Authority:	Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Keywords provided by University Hospital Inselspital, Berne:

inguinal hernia
laparoscopy
mesh

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Recurrence
Pathological Conditions, Anatomical

Hernia, Abdominal
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013