Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02406118|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Procedure: Transanal total mesorectal excision||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision|
|Actual Study Start Date :||March 1, 2015|
|Actual Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 2020|
Experimental: Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision
Procedure: 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.
Other Name: Laparoscopy-assisted transanal TME
- TME quality & circumferential resection margin (CRM) [ Time Frame: the day of trananal TME ]
The quality of the mesorectum was determined using pathology reports and scored using three grades:
- Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.
- Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.
- Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
- 30-day postoperative complications [ Time Frame: 1 month after surgery ]
- Number of harvested Lymph Nodes [ Time Frame: the day of surgery ]
- 2-year local recurrence free survival [ Time Frame: 2 years after surgery ]
- 5-year overall survival [ Time Frame: 5 years after surgery ]
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): NCT02406118
|Korea, Republic of|
|National Cancer Center|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||Dae Kyung Sohn||NCC,Korea|