title: COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer.
abstract: 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.
authors.affiliation: Department of Surgery, VU University Medical Centre, Postbus 7057, 1007 MB, Amsterdam, The Netherlands. c.deijen@vumc.nl.
authors.forename: Charlotte L
authors.initials: CL
authors.lastname: Deijen
authors.affiliation: Department of Surgery, Gelderse Vallei Hospital Ede, Ede, The Netherlands.
authors.forename: Simone
authors.initials: S
authors.lastname: Velthuis
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Alice
authors.initials: A
authors.lastname: Tsai
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Stella
authors.initials: S
authors.lastname: Mavroveli
authors.affiliation: Department of Surgery, VU University Medical Centre, Postbus 7057, 1007 MB, Amsterdam, The Netherlands.
authors.forename: Elly S M
authors.initials: ES
authors.lastname: de Lange-de Klerk
authors.affiliation: Department of Surgery, Gelderse Vallei Hospital Ede, Ede, The Netherlands.
authors.forename: Colin
authors.initials: C
authors.lastname: Sietses
authors.affiliation: Department of Surgery, VU University Medical Centre, Postbus 7057, 1007 MB, Amsterdam, The Netherlands.
authors.forename: Jurriaan B
authors.initials: JB
authors.lastname: Tuynman
authors.affiliation: Department of Surgery, Hospital Clinic de Barcelona, Barcelona, Spain.
authors.forename: Antonio M
authors.initials: AM
authors.lastname: Lacy
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: George B
authors.initials: GB
authors.lastname: Hanna
authors.affiliation: Department of Surgery, VU University Medical Centre, Postbus 7057, 1007 MB, Amsterdam, The Netherlands.
authors.forename: H Jaap
authors.initials: HJ
authors.lastname: Bonjer
mesh_terms: D001003:Anal Canal; D002277:Carcinoma / Q000601:surgery*; D013505:Digestive System Surgical Procedures / Q000379:methods; D018572:Disease-Free Survival; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D000072662:Margins of Excision; D008643:Mesentery / Q000601:surgery*; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology*; D059351:Organ Sparing Treatments; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000601:surgery*; D012007:Rectum / Q000601:surgery*; D015996:Survival Rate; D000067368:Transanal Endoscopic Surgery / Q000379:methods*
keywords: Laparoscopic; Rectal cancer; Surgical quality; TME; TaTME; Total mesorectal excision; Transanal