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The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case.
Difficult case is defined as below;
- If any one of the following (1 or 2 or 3)
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 | Laparoscopy-assisted transanal total mesorectal excision |
|
| 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 surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day postoperative complications | The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management. Grade V: Death of a patient |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year local recurrence free survival | 2 years after surgery | |
| 5-year overall survival | 5 years after surgery |
Inclusion Criteria:
age: 20-80 years
biopsy-proven adenocarcinoma of the rectum
clinical staging (c or yc): T0-3, N0-2, M0
Rectal cancer located 3-12 cm from the anal verge
ECOG performance status: 2 or less
If any one of the following (1 or 2 or 3)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Kyung Sohn, MD, PHD | Korea: National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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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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| 1 month after surgery |
| Number of harvested Lymph Nodes | the day of surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |