Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

The University of Hong Kong (HKU)

Status: Completed

Conditions: Seroma; Hernia, Inguinal

Treatments: Procedure: Monopolar energy; Procedure: Blunt dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT03665883

HERN-MONOPOLAR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 2 patient groups

Diathermy preferred

Active Comparator group

Description:

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

Treatment:

Procedure: Monopolar energy

Blunt dissection preferred

Active Comparator group

Description:

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

Treatment:

Procedure: Blunt dissection