Viewing Study NCT03413930



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Last Modification Date: 2024-10-26 @ 12:39 PM
Study NCT ID: NCT03413930
Status: WITHDRAWN
Last Update Posted: 2020-02-17
First Post: 2018-01-22

Brief Title: Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
Sponsor: Ruijin Hospital
Organization: Ruijin Hospital

Study Overview

Official Title: Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer
Status: WITHDRAWN
Status Verified Date: 2020-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: No funding was raised
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision TaTME for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excisionLaTME
Detailed Description: Colorectal cancer CRC including rectal cancer is one of the most common gastrointestinal tumors and its incidence is third in the world At presentsurgical treatments is the main means to cure CRC Total mesorectal excision TME is the gold standard for rectal cancer surgery Transanal total mesorectal excision TaTME was recently developed to overcome technical difficulties associated with LaTME and open TME Most reports are retrospective studies More studies especially large-scale randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancerThis is a single-center open-label non-inferiority randomized controlled trial A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 11 ratio It will provide valuable clinical evidence for the objective assessment of the oncological safetyefficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer

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