Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06105203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-09-03
Brief Title:
RATME vs LATME in Middle and Low Rectal Cancer
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients With Middle and Low Rectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
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:
This is a multicenter superior randomized controlled trial designed to compare Robotic-assisted total mesorectal excision RATME and laparoscopic-assisted total mesorectal excision LATME for middle and low rectal cancer The primary endpoint is the incidence of intersphincteric resection ISR The secondary outcomes are coloanal anastomosis CAA conversion to open conversion to transanal TME TaTME incidence of abdominoperineal resection APR postoperative morbidity and mortality within 30 days after surgery pathological outcomes long-term survival outcomes functional outcomes and quality of life
Detailed Description:
Robotic-assisted total mesorectal excision RATME has been gradually applied by colorectal surgeons Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision TME in rectal cancer especially middle and low rectal cancer with a narrow pelvis Therefore this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME LATME in middle and low rectal cancer
This is a multicenter superior randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer The primary endpoint is the incidence of intersphincteric resection ISR The secondary outcomes are coloanal anastomosis CAA conversion to open conversion to transanal TME TaTME incidence of abdominoperineal resection APR postoperative morbidity and mortality within 30 days after surgery pathological outcomes long-term survival outcomes functional outcomes and quality of life In addition certain measures will be conducted to ensure quality and safety including centralized photography review and semiannual assessment
This is a multicenter superior randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer The primary endpoint is the incidence of intersphincteric resection ISR The secondary outcomes are coloanal anastomosis CAA conversion to open conversion to transanal TME TaTME incidence of abdominoperineal resection APR postoperative morbidity and mortality within 30 days after surgery pathological outcomes long-term survival outcomes functional outcomes and quality of life In addition certain measures will be conducted to ensure quality and safety including centralized photography review and semiannual assessment
Study Oversight
Has Oversight DMC:
None
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?:
None