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Stapler Versus Glue for Laparoscopic Groin Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793286
First Posted: November 19, 2008
Last Update Posted: November 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Stapler Versus Glue for Laparoscopic Groin Hernia Repair

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Recurrence [ Time Frame: 6 weeks, 6 months, 12 months postoperative ]

Secondary Outcome Measures:
  • postoperative pain [ Time Frame: 6 weeks, 6 months, 12 months postoperative ]
  • sensibility disorder [ Time Frame: 6 weeks, 6 months, 12 months postoperative ]
  • intra- and postoperative complications [ Time Frame: 6 weeks, 6 months, 12 months postoperative ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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
First Submitted: November 18, 2008
First Posted: November 19, 2008
Last Update Posted: November 24, 2008
Last Verified: November 2008

Keywords provided by University Hospital Inselspital, Berne:
inguinal hernia
laparoscopy
mesh

Additional relevant MeSH terms:
Hernia
Recurrence
Hernia, Inguinal
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Hernia, Abdominal