COLOR III

Trial Overview

Acronym	COLOR III
Number	1
Protocol Link	http://www.color3trial.com/wp-content/uploads/2017/01/C1.-Research-protocol-version-5-dd-28-11-2016-clean.pdf
Public Trial Registry Link	https://clinicaltrials.gov/ct2/show/NCT02736942
Status	Open/recruiting
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Surgery

Trial Description

The COLOR III trial is an international multicenter randomized study comparing short- and long term outcomes of TaTME and laparoscopic TME for rectal cancer. The design is non-inferiority compared to conventional laparoscopic surgery. The study will include a quality assessment phase before entering the randomization-phase to ensure required competency level and uniformity of the new TaTME technique and the laparoscopic TME. During the trial the clinical data will be reviewed centrally to ensure

Chief Investigator

H.J. Bonjer
Prof. dr

Profile Link

Lead Centre

Amsterdam UMC location VUMC
De Boelelaan 1117
Amsterdam
1081 HV
The Netherlands

Website

Additional Information

Full Research Summary

Objective:	The COLOR III trial is an international multicenter randomized study comparing short- and long term outcomes of TaTME and laparoscopic TME for rectal cancer. The design is non-inferiority compared to conventional laparoscopic surgery. The study will include a quality assessment phase before entering the randomization-phase to ensure required competency level and uniformity of the new TaTME technique and the laparoscopic TME. During the trial the clinical data will be reviewed centrally to ensure uniform quality.
Aim:	The COLOR III trial is an international multicenter randomized study comparing short- and long term outcomes of TaTME and laparoscopic TME for rectal cancer. The design is non-inferiority compared to conventional laparoscopic surgery. The study will include a quality assessment phase before entering the randomization-phase to ensure required competency level and uniformity of the new TaTME technique and the laparoscopic TME. During the trial the clinical data will be reviewed centrally to ensure uniform quality.
Methods:	RCT
Reason for International Trial:	.