Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Not Applicable

• Conditions: Large Rectal Adenomas; Early Rectal Cancer

• Registration Number: NCT03718351
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Brief Summary

Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-24
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06
• Primary Completion: 2021-09-24
• Study Completion: 2021-09-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• The lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
• Have signed approved informed consent form for the study
• preoperative stage uT0 and/or uT1, mrT0 and/or mrT1

Exclusion Criteria

• non-epithelial tumors
• tumors </= 3 cm in size
• recurrent tumors
• suspicion of lymph node metastasis (N + disease)
• preoperative stage uT2 and/or mrT2
• mucous or low-grade adenocarcinoma
• preoperative stage rM1 and/or uM1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
En-block resesction rate	14 day
R0 resection rate	14 day

Secondary Outcome Measures

Name	Time	Method
Incidence of locoregional recurrence	12 months
Morbidity defined by the Clavien-Dindo classification	30 day

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation