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| Name | Class |
|---|---|
| The University of Hong Kong-Shenzhen Hospital | OTHER |
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This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. Other secondary outcomes will be measured including post-operative pain, discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.
Inguinal hernia is a common disease and causes significant morbidity if left untreated. With the advances of laparoscopic approach of extra-peritoneal hernioplasty, it significantly reduces the post-operative pain and lead to a better quality of life with higher acceptance to patients.However, similar to traditional Litchenstein approach, post operative seroma formation is still a common problem encountered after surgery. Numerous method has been described to reduce chance of seroma formation, however, none was proven to be effective except pre-peritoneal drainage. There are currently 2 large retrospective non-randomized cohort study to evaluate the effectiveness of preperitoneal drainage available for reference. We therefore study the feasibility and efficacy of preperitoneal drainage with large scale randomized trial.
Patient fulfill inclusion criteria and consent to surgery and study will be recruited. A standardized pre-peritoneal dissection and mesh placement will be adopted. Immediately before deflation of pre-peritoneal space, randomization will be performed by calling research assistant for study group using computer generated code. Drain will be placed for 23 hours after operation and ultrasonography will be performed immediately after removal of drain. USG will be repeated at post-operative 1 week, 1 month, 3 months, 6 months and 1 year after surgery. For non-drain group, a fake drain will be attach to the skin of the wound to achieve double blinding to patients and assessors. In addition to seroma, patient demographics and secondary outcome including post-operative pain score, discomfort, foreign body sensation, patient satisfaction, infection, recurrence, etc will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drain | Experimental | preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia |
|
| No-drain | No Intervention | No drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preperitoneal suction drainage | Procedure | preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative day 1 |
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative day 7 |
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative 1 month |
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative 3 month |
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative 6 month |
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain after TEP hernioplasty | Post-operative pain after TEP hernioplasty will be assessed by self-evaluated VAS questionnaire during initial 7 days after operation. Then will be asked by independent assessor upon follow-up | post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year |
| Analgesic used after after TEP hernioplasty |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joe KM Fan, MBBS,MS,FRCS | Contact | +86-18307555114 | drjoefan@hku.hk | |
| WL Law, MBBS,MS,FRCS | Contact | +852-22554763 | lawwl@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Joe KM Fan, MBBS,MS,FRCS | The University of Hong Kong | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, The University of Hong Kong - Shenzhen Hospital | Recruiting | Shenzhen | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19542859 | Result | Ismail M, Garg M, Rajagopal M, Garg P. Impact of closed-suction drain in preperitoneal space on the incidence of seroma formation after laparoscopic total extraperitoneal inguinal hernia repair. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):263-6. doi: 10.1097/SLE.0b013e3181a4d0e1. | |
| 25238803 | Result | Gao D, Wei S, Zhai C, Chen J, Li M, Gu C, Wu H. Clinical research of preperitoneal drainage after endoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2015 Oct;19(5):789-94. doi: 10.1007/s10029-014-1310-0. Epub 2014 Sep 20. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 10, 2018 | |
| Reset | Feb 8, 2019 | |
| Release | Apr 1, 2020 | |
| Reset | Apr 14, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 10, 2018 | Feb 8, 2019 | |||
| Apr 1, 2020 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| post-operative 1 year |
Number of analgesic used after after TEP hernioplasty will be assessed by self-evaluated questionnaire during initial 7 days after operation. Then will be asked by independent assessor upon follow-up |
| post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year |
| Chronic discomfort after TEP hernioplasty | Chronic discomfort after TEP hernioplasty will be asked by independent assessor upon follow-up | post-operative 1 month, 3 month, 6 month, 1 year |
| Hernia recurrence after TEP hernioplasty | Hernia recurrence after TEP hernioplasty will be assessed by independent assessor upon follow-up | post-operative 1 month, 3 month, 6 month, 1 year |
| Patient satisfaction after TEP hernioplasty | Patient satisfaction after TEP hernioplasty will be asked by independent assessor upon follow-up | post-operative 1 month, 3 month, 6 month, 1 year |
| Apr 14, 2020 |