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The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transanal total mesorectal excision | Experimental | Laparoscopy-assisted transanal total mesorectal excision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal total mesorectal excision | Procedure | Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| TME quality & circumferential resection margin (CRM) | The quality of the mesorectum was determined using pathology reports and scored using three grades:
| the day of trananal TME |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day postoperative complications | 1 month after surgery | |
| Number of harvested Lymph Nodes | the day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year local recurrence free survival | 2 years after surgery | |
| 5-year overall survival | 5 years after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Kyung Sohn | NCC,Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29624549 | Derived | Park SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |