COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer

• DOI: 10.1007/s00464-015-4615-x
• Publication Date: 2015-11-04T16:07:34Z
• Authors: Charlotte L. Deijen; Simone Velthuis; Alice Tsai; Stella Mavroveli; Elly S. M. de Lan...; Colin Sietses; Jurriaan B. Tuynman; Antonio M. Lacy; George B. Hanna; H. Jaap Bonjer
• Keywords: 610; Anal Canal; Article; Disease-Free Survival; 03 medical and health sciences; Laparoscopic; 0302 clinical medicine; Transanal; 617; Humans; Mesentery; Rectal cancer; Digestive System Surgical Procedures; Transanal Endoscopic Surgery; Rectal Neoplasms; Carcinoma; TME; Rectum; Margins of Excision; 1103 Clinical Sciences; TaTME; 3. Good health; Survival Rate; Quality of Life; Surgery; Laparoscopy; Neoplasm Recurrence, Local; Organ Sparing Treatments; Surgical quality; Total mesorectal excision

Total mesorectal excision (TME) is an essential component of surgical management of rectal cancer. Both open and laparoscopic TME have been proven to be oncologically safe. However, it remains a challenge to achieve complete TME with clear circumferential resections margin (CRM) with the conventional transabdominal approach, particularly in mid and low rectal tumours. Transanal TME (TaTME) was developed to improve oncological and functional outcomes of patients with mid and low rectal cancer.An international, multicentre, superiority, randomised trial was designed to compare TaTME and conventional laparoscopic TME as the surgical treatment of mid and low rectal carcinomas. The primary endpoint is involved CRM. Secondary endpoints include completeness of mesorectum, residual mesorectum, morbidity and mortality, local recurrence, disease-free and overall survival, percentage of sphincter-saving procedures, functional outcome and quality of life. A Quality Assurance Protocol including centralised MRI review, histopathology re-evaluation, standardisation of surgical techniques, and monitoring and assessment of surgical quality will be conducted.The difference in involvement of CRM between the two treatment strategies is thought to be in favour of the TaTME. TaTME is therefore expected to be superior to laparoscopic TME in terms of oncological outcomes in case of mid and low rectal carcinomas.