Clinical Trials Directory

Trials / Completed

CompletedNCT03665883

Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
103 (actual)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREMonopolar energyMonopolar energy in TEP for inguinal hernia
PROCEDUREBlunt dissectionBlunt dissection in TEP for inguinal hernia

Timeline

Start date
2018-09-01
Primary completion
2019-10-01
Completion
2019-12-01
First posted
2018-09-11
Last updated
2020-03-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03665883. Inclusion in this directory is not an endorsement.