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Stapler Versus Glue for Laparoscopic Groin Hernia Repair

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00793286
First received: November 18, 2008
Last updated: November 21, 2008
Last verified: November 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Disease Attributes
Hernia, Abdominal
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014