Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

Phase 3

Completed

• Conditions: Hernia
• Interventions: Device: Fibrin sealant spray; Device: Mechanical stapling

• Registration Number: NCT01727050
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-11
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-15
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin sealant spray	Fibrin sealant spray	-
Mechanical stapling	Mechanical stapling	-

Primary Outcome Measures

Name	Time	Method
Incidence of chronic pain	6 months

Secondary Outcome Measures

Name	Time	Method
Morbidities	30 day
Recurrence rate	6 month
Severity of acute pain	1 week
Quality of life assessment	6 months

Trial Locations

Locations (1)

Department of Surgery, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong