Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

Hernia, Inguinal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665883
• Other study ID #: HERN-MONOPOLAR-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Seroma

Intervention

Procedure:
• Monopolar energy
Monopolar energy in TEP for inguinal hernia
• Blunt dissection
Blunt dissection in TEP for inguinal hernia

Locations

Country	Name	City	State
China	Department of Surgery, The University of Hong Kong - Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drain output at 23 hours post-operation	pre-peritoneal drain output (in ml) at 23 hours post-operation	23 hours post operation
Secondary	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
Secondary	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
Secondary	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
Secondary	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