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Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

Not Applicable
Completed
Conditions
Seroma
Hernia, Inguinal
Interventions
Procedure: Blunt dissection
Procedure: Monopolar energy
Registration Number
NCT03665883
Lead Sponsor
The University of Hong Kong
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
103
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Blunt dissection preferredBlunt dissectionBlunt 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
Diathermy preferredMonopolar energyMonopolar 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
Primary Outcome Measures
NameTimeMethod
Drain output at 23 hours post-operation23 hours post operation

pre-peritoneal drain output (in ml) at 23 hours post-operation

Secondary Outcome Measures
NameTimeMethod
Seroma at 23 hours post-operation23 hours post operation

Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm.

Pain score at first week1 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.

Seroma at 1 week post-operation1 week post operation

Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm.

Seroma at 1 month post-operation1 month post-operation

Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm.

Trial Locations

Locations (1)

Department of Surgery, The University of Hong Kong - Shenzhen Hospital

🇨🇳

Shenzhen, Guangdong, China

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