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: | . |