Clinical Trials Logo
  1. Home
  2. Rectal Neoplasms
  3. NCT06105203

RATME vs LATME in Middle and Low Rectal Cancer

Rectal Neoplasms Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06105203
Study type Interventional
Source The First Hospital of Jilin University
Contact Yuchen Guo, Ph.D.
Phone +8613630598312
Email guoyuchen8688@live.com
Status Not yet recruiting
Phase N/A
Start date January 1, 2024
Completion date January 2031
View Details
See also
  Status Clinical Trial Phase
Completed NCT02537340 - PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
Recruiting NCT02565667 - A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler N/A
Terminated NCT02538913 - Exercise Training for Rectal Cancer Patients N/A
Not yet recruiting NCT02439086 - Prediction of Response to Neoadjuvant Therapy in Rectal Cancer N/A
Completed NCT02233374 - Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET N/A
Completed NCT00535041 - Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
Recruiting NCT04949646 - Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision N/A
Recruiting NCT04095468 - Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Recruiting NCT06017583 - Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer Phase 3
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT04006951 - Development of a Clinical and Biological Database in Rectum Cancer N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT03714490 - MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer Phase 2
Recruiting NCT03325361 - The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage N/A
Completed NCT02252250 - Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer N/A
Completed NCT04455737 - Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Completed NCT01816607 - Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Completed NCT01721785 - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer N/A
Active, not recruiting NCT01171300 - Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients N/A