Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT02421432
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2015-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases
Sponsor:
National Cancer Center, Korea
Organization:
Study Overview
Official Title:
A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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)
1. BMI: 30 or more
2. Tumor size: more than 7cm in long diameter
3. CRM: mesorectal fascia involvement or less than 1 mm on MRI
Difficult case is defined as below;
\- If any one of the following (1 or 2 or 3)
1. BMI: 30 or more
2. Tumor size: more than 7cm in long diameter
3. CRM: mesorectal fascia involvement or less than 1 mm on MRI
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: