Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

Not yet recruiting

• Conditions: Rectal Neoplasms

• Registration Number: NCT06902701
• Lead Sponsor: Turkish Society of Colon and Rectal Surgery

Brief Summary

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.

Detailed Description

Colorectal cancer (CRC) is one of the most common malignancies globally, with early-stage rectal neoplasms being increasingly diagnosed due to widespread screening programs. This trend has led to a greater focus on organ-preserving treatment options, with endoscopic submucosal dissection (ESD) and transanal endoscopic surgery (TES) emerging as key techniques for local excision. ESD allows for en bloc resection of superficial lesions with high histological completeness but has a steep learning curve and a higher perforation risk. In contrast, TES, performed using transanal minimally invasive surgery (TAMIS) or transanal endoscopic operation (TEO), facilitates full-thickness excision and is more commonly used in Western surgical practice.

Each technique presents unique advantages and challenges. ESD is minimally invasive, preserves rectal function, and reduces postoperative complications such as fecal incontinence. However, its prolonged procedure time and technical difficulty limit its widespread adoption. TES, utilizing standard laparoscopic instruments, offers superior visualization and facilitates excision of deeper lesions but may lead to rectal wall defects, increased postoperative pain, and anorectal dysfunction. While studies suggest similar en bloc and recurrence rates between the two methods, discrepancies exist in procedural efficiency, hospital stay, and morbidity rates, with ESD potentially offering a shorter hospitalization period in certain cases.

Despite the increasing use of ESD and TES, a clear consensus on the optimal approach for early rectal neoplasms remains lacking. Existing data, primarily from high-volume centers in Asia, may not be fully applicable to Western populations. To address these gaps, this study aims to conduct a prospective, multi-center observational comparison of ESD and TES, assessing key outcomes such as recurrence rates, resection quality, complications, and hospital stay. The findings will contribute to refining treatment strategies and improving clinical decision-making for rectal neoplasm management.

Study Timeline

• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-03-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Study Start: 2025-07-01
• Primary Completion: 2027-06-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R0 Resection Rate	Immediately post-procedure.	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	12 months post-procedure.	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.

Secondary Outcome Measures

Name	Time	Method
En Bloc Resection Rate	Immediately post-procedure.	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	Immediately post-procedure.	Total duration of the procedure (minutes).
Complication Rate	Up to 30 days post-procedure.	Incidence of adverse events, including all intraoperative and postoperative according to Clavien-Dindo classification.
Length of Hospital Stay	Perioperative/Periprocedural	Duration of hospitalization (days).
Fecal Incontinence	Pre-procedure and within the first 12 months post-procedure.	Patient-reported outcomes will be assessed using the Wexner Incontinence Score, a validated instrument that quantifies the frequency and severity of fecal incontinence. Scores range from 0 (perfect continence) to 20 (complete incontinence), with higher scores indicating greater dysfunction.

Trial Locations

Locations (5)

Private Office; 🇹🇷 Istanbul, Turkey

Baskent University; 🇹🇷 Istanbul, Turkey

Memorial Sisli Hospital; 🇹🇷 Istanbul, Turkey

Dokuz Eylul University; 🇹🇷 Izmir, Turkey

Acibadem Kent Hospital; 🇹🇷 Izmir, Turkey