Hernia, Inguinal, Seroma
Conditions
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.
Interventions
PROCEDUREMonopolar energy
Monopolar energy in TEP for inguinal hernia
PROCEDUREBlunt dissection
Blunt dissection in TEP for inguinal hernia
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients, assessors and investigators will be blinded on patient group.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drain output at 23 hours post-operation | 23 hours post operation | pre-peritoneal drain output (in ml) at 23 hours post-operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroma at 23 hours post-operation | 23 hours post operation | Size of seroma at 23 hours post-operation measured by ultrasonography in 3 dimension in mm. |
| Seroma at 1 week post-operation | 1 week post operation | Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm. |
| Pain score at first week | 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. |
| Seroma at 1 month post-operation | 1 month post-operation | Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm. |
Countries
China
Outcome results
None listed