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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diathermy preferred | Active Comparator | 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 |
|
| Blunt dissection preferred | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monopolar energy | Procedure | Monopolar energy in TEP for inguinal hernia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Drain output at 23 hours post-operation | pre-peritoneal drain output (in ml) at 23 hours post-operation | 23 hours post operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Seroma at 1 week post-operation | Size of seroma at 1 week post-operation measured by ultrasonography in 3 dimension in mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe KM FAN, MS(HKU) | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, The University of Hong Kong - Shenzhen Hospital | Shenzhen | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29681018 | Background | 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. No abstract available. | |
| 29332240 |
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| ID | Term |
|---|---|
| D049291 | Seroma |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
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the effect on seroma formation and output of pre-peritoneal drain after TEP by monoploar diathermy or blunt dissection approach will be studied
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Patients, assessors and investigators will be blinded on patient group.
| Blunt dissection |
| Procedure |
Blunt dissection in TEP for inguinal hernia |
|
| 1 week post operation |
| 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 |
| 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 |
| Result |
| 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 trial. Hernia. 2018 Jun;22(3):455-465. doi: 10.1007/s10029-018-1731-2. Epub 2018 Jan 13. |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |