Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia
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|ClinicalTrials.gov Identifier: NCT03665883|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Seroma Hernia, Inguinal||Procedure: Monopolar energy Procedure: Blunt dissection||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Patients, assessors and investigators will be blinded on patient group.|
|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|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2021|
Active Comparator: Diathermy preferred
Monopolar energy is the preferred dissection approach in this group of patients undergo TEP. Total time of activation of monopolar machine will recorded by specially designed device
Procedure: Monopolar energy
Monopolar energy in TEP for inguinal hernia
Active Comparator: Blunt dissection preferred
Blunt dissection is the preferred dissection approach in this group of patients undergo TEP. Use of monopolar energy for haemostasis is still allowed upon surgeons' decision. Total time of activation of monopolar machine will recorded by specially designed device
Procedure: Blunt dissection
Blunt dissection in TEP for inguinal hernia
- Drain output at 23 hours post-operation [ Time Frame: 23 hours post operation ]pre-peritoneal drain output (in ml) at 23 hours post-operation
- Seroma 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.
- Seroma at 1 week post-operation [ Time Frame: 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 [ 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.
- Seroma at 1 month post-operation [ Time Frame: 1 month post-operation ]Size of seroma at 1 month post-operation measured by ultrasonography in 3 dimension in mm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665883
|Contact: Joe KM FAN, MS(HKU)||email@example.com|
|Department of Surgery, The University of Hong Kong - Shenzhen Hospital||Recruiting|
|Shenzhen, Guangdong, China|
|Contact: Joe KM Fan, MBBS,MS,FRCS +86-18307555114 firstname.lastname@example.org|
|Principal Investigator: JW Liu|
|Sub-Investigator: XF Yang|
|Sub-Investigator: KJ Chen|
|Sub-Investigator: L Jiang|
|Sub-Investigator: ZH Liu|
|Sub-Investigator: GX Zhang|
|Sub-Investigator: Fion SY Chan, MBBS|
|Principal Investigator:||Joe KM FAN, MS(HKU)||The University of Hong Kong|