Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia
- Conditions
- SeromaHernia, Inguinal
- Interventions
- Procedure: Blunt dissectionProcedure: 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
- Age above 18 and below 90
- Male or female patients
- Unilateral inguinal hernia
- First occurrence hernia
- Consent to laparoscopic hernioplasty for inguinal hernia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blunt dissection preferred Blunt dissection 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 Diathermy preferred Monopolar energy 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
- Primary Outcome Measures
Name Time Method Drain output at 23 hours post-operation 23 hours post operation pre-peritoneal drain output (in ml) at 23 hours post-operation
- Secondary Outcome Measures
Name Time Method Seroma at 23 hours post-operation 23 hours post operation Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm.
Pain score at first week 1 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-operation 1 week post operation Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm.
Seroma at 1 month post-operation 1 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