Transanal minimally invasive surgery plus preoperative short-course radiotherapy versus laparoscopic total mesorectal exision in T2N0M0 rectal tumours treatment: a randomized clinical trial

Abstract

TITLE: Transanal minimally invasive surgery plus preoperative short-course radiotherapy versus laparoscopic total mesorectal excision in T2N0M0 rectal tumours treatment. BACKGROUND: Colorectal cancer is the third most incident cancer worldwide and the first at Girona province. Radical resection for rectal cancer treatment, such as Total Mesorectal Excision (TME), is accompanied with high morbidity (permanent stomas, bleeding) and poor long term functional outcome (sexual dysfunction, faecal and urinal incontinence), as it involves the dissection of planes closely related to nervous structures in order to excise the mesorectum. The implementation of screening programs will probably show a shift towards more early staged cancers and TME could be seen as an overtreatment for this group of patients, despite its excellent oncological outcomes that had make TME the gold-standard for surgical treatment of late stage I cancers (T2N0M0). Transanal Minimally invasive surgery (TAMIS) is a new approach for rectal tumours treatment, with excellent functional outcomes. As a local excision procedure it’s much less invasive and aggressive than radical resections, but local recurrence rates are much higher than in TME, as it only removes the tumour confined to the rectal wall, while possible nodal metastases undetected by stage methods can remain within the mesorectum. Neoadjuvant treatments like short-course radiotherapy (SC-RT) combined with TAMIS can be a solution to properly treat these early-staged carcinomas. OBJECTIVE: This study aims to assess if TAMIS plus SC-RT is non-inferior to laparoscopic TME, regarding overall survival. Results over local recurrences, complication rate, cancer-specific survival, quality of life, sexual function and faecal continence will also be assessed. STUDY DESIGN AND METHODS: In this multicentre trial, patients with clinical staged T2N0M0 rectal cancer will be randomized between TAMIS plus neoadjuvant SC-RT and laparoscopic total mesorectal excision. A sample of 352 patients will enter into the study through a non-probabilistic consecutive recruitment. Data will be collected with questionnaires and tests, preoperatively and postoperatively in each follow-up appointment. Patients who will undergone the experimental approach will be under an extensive follow-up