Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

Conditions
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Hernia

Intervention / Treatment
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* Device: Fibrin sealant spray
* Device: Mechanical stapling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical stapling<br> | Device: Mechanical stapling<br>* Fixation of mesh would be performed using mechanical staplers<br>|
| Active Comparator: Fibrin sealant spray<br> | Device: Fibrin sealant spray<br>* Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic pain |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of acute pain |  | 1 week | 
| Morbidities |  | 30 day | 
| Recurrence rate |  | 6 month | 
| Quality of life assessment |  | 6 months |