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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03665883
Other study ID # HERN-MONOPOLAR-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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