OPEN Research Support
head

M.D PhD.
Issam al-Najami
Department of surgery


Projekt styring
Projekt status    Open
 
Data indsamlingsdatoer
Start 01.12.2021  
Slut 01.12.2027  
 



Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for mid to Low Rectal cancer Surgery Evaluation Trial in the hands of an experienced surgeon Internal Reference Number / Short title: ROTA

Short summary

Recent novel surgical techniques for resection of low rectal cancer have been introduced. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). There is no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experience surgeons. This study is the first set about to assess the differences in short and longterm outcomes for the two procedures.


Rationale

Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). There is no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experience surgeons.

An experienced surgeon is defined as those who have done at least 80 RLAR or TaTME. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve. We suspect that by excluding the surgeons on learning curve, the true oncological outcomes and functional outcomes can be measured more accurately.

The primary objective of this study is to obtain the first head to head comparison of the two surgical procedures.


Description of the cohort

This is an observational prospective, multicentre trial. Patients will be assigned either RLAR or TaTME depends on the chosen centres. The study will include 330 patients from UK and a number of international sites including, but not limited to Denmark, South Korea, USA and the Netherlands.


Data and biological material

All demographic data will be noted in a redcap database. In addition and in the same database all data on short and longterm outcomes and patient reported outcomes will be noted from national and internayional centres.