Department of Surgery, The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
NCT Number: NCT03665883
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Shenzhen, Guangdong, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Monopolar energy in TEP for inguinal hernia
Blunt dissection in TEP for inguinal hernia
Time frame: 23 hours post operation
pre-peritoneal drain output (in ml) at 23 hours post-operation
Time frame: 23 hours post operation
Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm.
Time frame: 1 week post operation
Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm.
Time frame: 1 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.
Time frame: 1 month post-operation
Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm.
The University of Hong Kong
Other
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
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