A multicenter non-inferiority randomized clinical trial is proposed to compare two types of treatment for early rectal neoplastic lesions. Study arms:~Endoscopic treatment: Endoscopic Submucosal Dissection (ESD)~Minimally invasive laparoscopic local surgical treatment: Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO).~Aims:~Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) of rectal lesions after ESD vs Surgical treatment (TAMIS/TEO).~Secondary aims: Both arms of the study are compared according to other efficacy-related variables (en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate [6 months]), safety (rate of complications), morbidity (comparing different specific indexes: Wexner index, EQ-5L-5D, etc) and cost-effectiveness analyses (QALY).~Inclusion criteria:~Patients older than 18 y/o~Non-pedunculated rectal lesions (sessile 0-Is or flat 0-II) greater than 20 mm in diameter.~The edges of the lesion should be more than 3 cm from the external anal margin and up to 14 cm from it.~Circumferential involvement <50%~Exclusion criteria:~Patients who refuse to participate.~Diagnosis of inflammatory bowel disease with rectal involvement.~Pregnant.~Anorectal fibrosis due to previous anorectal surgery.~Lateral Spreading Lesions (LST classification) Granular Homogeneous type~Lesions greater than 50 mm when there is suspicion of advanced histology (Kudo Vi superficial pattern).~Rectal lesions of any size with high suspicion of deep submucosal invasion or locoregional lymph node involvement, either in the diagnostic colonoscopy (Kudo Vn crypt pattern, NICE 3 pattern, Sano IIIB pattern) or by complementary imaging tests (rectal EUS/Pelvic MRI)~Existence of synchronous colorectal lesions that require other surgical treatment in any case.~N-size estimation:~Assuming a global rate of long-term local recurrence in rectal lesions treated by TAMIS/TEO or ESD of 2.5% (using the data available in the medical literature), considering a non-inferiority limit of 10%, power of 80% (Beta error 0.2, alpha error 0.05) and assuming a loss of patients during the follow-up around 10%, 34 patients per group are required.~Follow-up and Information collect:~The follow-up will be of 1 year from the date of the intervention and the visits in which the information to be analyzed will be collected are adjusted to the usual clinical practice.~The data would be registered using the on-line database system for medical research RedCap.~Other information:~The entire protocol of this study has been approved by de Ethical Committee on Clinical Research of the Puerta de Hierro University Hospital.~The study counts with a Civil Responsibility Insurance policy.
A multicenter non-inferiority randomized clinical trial to compare Endoscopic treatment (ESD) and Minimally Invasive Laparoscopic Local Surgical Treatment (TAMIS or TEO) for early rectal neoplastic lesions (adenoma & T1CRC) Primary aim: To compare the long-term local recurrence rate (12 months after the procedure)~Secondary aims:~Compare en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate, safety (rate of complications), morbidity and cost-effectiveness analyses.