Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

Study Overview
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Brief Summary
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There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.

Detailed Description
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There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial. all male and female patients presented with first occurrence, unilateral inguinal hernia anticipated for laparoscopic TEP are included into study after informed consent. Patients are randomized into diathermy-preferred (DP) group and blunt dissection-preferred (BDP) group just before commence of operation after general anaethesia. Surgeons are instructed to use monopolar energy as main dissection method for whole operation if possible (DP), where as blunt dissection is the preferred choice in BDP group but it is allowed to use monopolar energy if needed. Total energy time is measured by a specially designed device attaching to the monopolar pedals as accurate as to millisecond (ms). Pre-peritoneal drains are inserted for drainage and removed 23 hours after operation. Energy time, drainage output, ultrasonic seroma sizes at day 1, day 6, 1 month post-operations, recurrence are compared between 2 groups.

Official Title
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Randomised Controlled Trial on Use of Monopolar Energy Versus Blunt Dissection in Totally Extra-peritoneal Hernioplasty (TEP) for Inguinal Hernia - the Effect on the Output of Pre-peritoneal Drain

Conditions
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Seroma, Hernia, Inguinal

Intervention / Treatment
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* Procedure: Monopolar energy
* Procedure: Blunt dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 and below 90 Male or female patients Unilateral inguinal hernia First occurrence hernia Consent to laparoscopic hernioplasty for inguinal hernia Exclusion Criteria: inguino-scrotal hernia Recurrent inguinal hernia Incarcerated hernia Bilateral inguinal hernia Bleeding tendency On anti-platelet agent or anti-coagulant Significant co-morbidies Patients with pacemaker Decline or not consent to

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: the effect on seroma formation and output of pre-peritoneal drain after TEP by monoploar diathermy or blunt dissection approach will be studied
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diathermy preferred<br>Monopolar energy is the preferred dissection approach in this group of patients undergo TEP. Total time of activation of monopolar machine will recorded by specially designed device | Procedure: Monopolar energy<br>* Monopolar energy in TEP for inguinal hernia<br>|
| Active Comparator: Blunt dissection preferred<br>Blunt dissection is the preferred dissection approach in this group of patients undergo TEP. Use of monopolar energy for haemostasis is still allowed upon surgeons' decision. Total time of activation of monopolar machine will recorded by specially designed device | Procedure: Blunt dissection<br>* Blunt dissection in TEP for inguinal hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain output at 23 hours post-operation | pre-peritoneal drain output (in ml) at 23 hours post-operation | 23 hours post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma at 23 hours post-operation | Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm. | 23 hours post operation | 
| Seroma at 1 week post-operation | Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm. | 1 week post operation | 
| Pain score at first week | Pain score at first week (from day 0 to day 6) will be measured in visual analogue scale from 0-10, with 0 is minimum and 10 is maximum score reported by patients. | 1 week | 
| Seroma at 1 month post-operation | Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm. | 1 month post-operation |