Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01727050
First received: November 12, 2012
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for the repair of primary unilateral inguinal hernia. Previous studies showed that patients underwent TEP have less post-operative pain and earlier return to normal activities. However, chronic pain is still a major issue affecting quality of life after TEP with a reported incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable pain had been reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS) in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for application of FS laparoscopically is now available which can achieve mesh fixation by using fewer amounts of FS.

In this study, the investigators aim to compare the effectiveness of using fibrin spray for mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized controlled trial by allocating patients in two study arm in random manner. The treatment group will have the mesh fixed by fibrin sealant spray, whereas the control group will have conventional mechanical staples for fixation. Operative procedures and post-operative management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month after operation to evaluate the operative results and the incidence of chronic pain. Any complications related to the mesh and operation will also be recorded.


Condition Intervention Phase
Hernia
Device: Fibrin sealant spray
Device: Mechanical stapling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Incidence of chronic pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of acute pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Morbidities [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  • Recurrence rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Quality of life assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: June 2007
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mechanical stapling Device: Mechanical stapling
Fixation of mesh would be performed using mechanical staplers
Active Comparator: Fibrin sealant spray Device: Fibrin sealant spray
Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive male patients aged between 18 to 70 years with reducible unilateral inguinal hernia undergoing day-case TEP under general anaesthesia will be considered eligible.

Exclusion Criteria:

  • Bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large inguinal-scrotal hernia, previous abdominal incision (including previous contralateral hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs, end-stage renal failure, cirrhosis, impaired cognitive function and those not consent to study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01727050

Locations
Hong Kong
Department of Surgery, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthony Teoh, Honorary Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01727050     History of Changes
Other Study ID Numbers: FSMSLH
Study First Received: November 12, 2012
Last Updated: November 16, 2012
Health Authority: Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee (CREC): Hong Kong

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014