Clinical trial NCT03665883: Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seroma
Hernia, Inguinal
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Drain output at 23 hours post-operation
timeFrame: 23 hours post operation
Secondary outcomes:
measure: Seroma at 23 hours post-operation
timeFrame: 23 hours post operation
measure: Seroma at 1 week post-operation
timeFrame: 1 week post operation
measure: Pain score at first week
timeFrame: 1 week
measure: Seroma at 1 month post-operation
timeFrame: 1 month post-operation
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Department of Surgery, The University of Hong Kong - Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: The University of Hong Kong
name: Joe KM FAN, MS(HKU)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Reply to Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomized controlled trial. Hernia. 2018 Jun;22(3):469-470. doi: 10.1007/s10029-018-1764-6. Epub 2018 Apr 21. No abstract available.
citation: Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Hernia. 2018 Jun;22(3):455-465. doi: 10.1007/s10029-018-1731-2. Epub 2018 Jan 13.