This prospective observational cohort study aims to compare the clinical and procedural outcomes of Endoscopic Submucosal Dissection (ESD) and Transanal Minimally Invasive Surgery (TAMIS) for the treatment of early-stage rectal neoplasia. The study will evaluate recurrence rates, en bloc resection rates, R0 resection rates, procedure time, complication rates, and length of hospital stay over a 1-year follow-up period. Data will be collected from patients treated at multiple centers with expertise in ESD and TAMIS.
Adult patients (>18 years)
Non-pedunculated (sessile) lesions larger than 2 cm.
Lesions located within 15 cm from the anal verge confirmed by sigmoidoscopy or magnetic resonance imaging (MRI)
Evidence of lymph node involvement, T2 rectal tumors, or distant metastasis on preoperative imaging modalities (MRI, ERUS, CT)
Previous attempt at endoscopic resection
Previous rectal surgery
Previous pelvic radiation therapy
Patients diagnosed with rectal neoplasia undergoing treatment with either ESD or TES at participating centers. Patients will be assigned to ESD or TES based on physician preference, patient choice, and institutional availability.
Cohort
Prospective
Endoscopic Submucosal Dissection (ESD)
Procedure/SurgeryEndoscopic excision of the rectal lesion by submucosal injection and circumferential mucosal incision using an electrosurgical knife with en-bloc resection intent
Transanal Endoscopic Surgery (TES)
Procedure/SurgeryTransanal endoscopic surgery procedures include Transanal Minimally Invasive Surgery (TAMIS) and Transanal Endoscopic Operation (TEO). TAMIS will be performed using a single-port transanal access platform with standard laparoscopic instruments, including a high-definition camera, an insufflation system, and endoscopic graspers. The lesion will be circumferentially excised using electrocautery or an energy device, ensuring full-thickness resection when necessary. The defect will be managed based on its size, with primary closure using absorbable sutures or left to heal by secondary intention. TEO will be conducted using a rigid transanal endoscopic platform with a stereoscopic optical system to enhance visualization. The lesion will be marked, and a full-thickness or submucosal excision will be performed using endoscopic instruments and electrosurgical devices. Post-resection, the rectal wall defect will be assessed, and primary closure will be performed when indicated to minimize post
R0 Resection Rate
Proportion of patients with histologically confirmed tumor-free margins. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023)
Recurrence Rate
Proportion of patients with tumor recurrence at follow-up endoscopy within 12 months, histologically confirmed from resected visible residual disease or, if absent, from scar biopsies.
En Bloc Resection Rate
Proportion of patients where the tumor was removed in a single piece. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023)
Procedure Time
Total duration of the procedure (minutes).
Complication Rate
Incidence of adverse events, including all intraoperative and postoperative according to Clavien-Dindo classification.
Length of Hospital Stay
Duration of hospitalization (days).
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