Stapler Versus Glue for Laparoscopic Groin Hernia Repair
Primary Purpose
Inguinal Hernia, Recurrence, Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mesh fixation by staples
Mesh fixation by glue
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia, laparoscopy, mesh
Eligibility 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
Sites / Locations
- Dep. of Visceral and Transplantsurgery, Bern University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
A
B
Arm Description
Mesh fixation by staples
Mesh fixation by glue
Outcomes
Primary Outcome Measures
Recurrence
Secondary Outcome Measures
postoperative pain
sensibility disorder
intra- and postoperative complications
Full Information
NCT ID
NCT00793286
First Posted
November 18, 2008
Last Updated
November 21, 2008
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT00793286
Brief Title
Stapler Versus Glue for Laparoscopic Groin Hernia Repair
Official Title
Stapler Versus Glue for Laparoscopic Groin Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Recurrence, Pain
Keywords
inguinal hernia, laparoscopy, mesh
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
Mesh fixation by staples
Arm Title
B
Arm Type
Other
Arm Description
Mesh fixation by glue
Intervention Type
Procedure
Intervention Name(s)
Mesh fixation by staples
Intervention Description
Mesh fixation by staples
Intervention Type
Procedure
Intervention Name(s)
Mesh fixation by glue
Other Intervention Name(s)
N-Butyl-2 Cyanoacrulat Glue
Intervention Description
Mesh fixation by glue
Primary Outcome Measure Information:
Title
Recurrence
Time Frame
6 weeks, 6 months, 12 months postoperative
Secondary Outcome Measure Information:
Title
postoperative pain
Time Frame
6 weeks, 6 months, 12 months postoperative
Title
sensibility disorder
Time Frame
6 weeks, 6 months, 12 months postoperative
Title
intra- and postoperative complications
Time Frame
6 weeks, 6 months, 12 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Beldi, MD
Organizational Affiliation
Dep. of Visceral and Transplantsurgery, Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Visceral and Transplantsurgery, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
12535413
Citation
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.
Results Reference
background
PubMed Identifier
8916874
Citation
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.
Results Reference
background
PubMed Identifier
11141218
Citation
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.
Results Reference
background
PubMed Identifier
10421299
Citation
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.
Results Reference
background
PubMed Identifier
11141220
Citation
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.
Results Reference
background
PubMed Identifier
9703604
Citation
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.
Results Reference
background
PubMed Identifier
15107485
Citation
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.
Results Reference
background
PubMed Identifier
12153636
Citation
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.
Results Reference
background
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Stapler Versus Glue for Laparoscopic Groin Hernia Repair
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