Comparison of Cold and Hot Loop Resection Techniques for the Removal of Medium-sized Benign Colon Tumors

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 25, 2023

Primary Completion Date

October 10, 2025

Study Completion Date

September 30, 2026

Conditions
Benign Colon Tumors
Interventions
PROCEDURE

Cold endoscopic mucosal resection

3-4 ml of solution is injected into the submucosal layer under the formation. The formation with the surrounding mucous membrane (at least 1 mm from the edge of the formation) is captured with a specialized or standard polypectomy loop available to the operator (depending on the randomization result). The formation is removed by mechanical cutting without using electric current.

PROCEDURE

Hot endoscopic mucosal resection

"3-4 ml of solution is injected into the submucosal layer under the formation. The formation with the surrounding mucous membrane (at least 1 mm from the edge of the formation) is captured with a specialized or standard diathermic polypectomy loop available to the operator (depending on the randomization result). The formation is removed using electric current in the Endocat mode (or its analogue, providing alternating cutting and coagulation under the control of a processor built into the electrical unit).~After the formation is removed, the resection site is examined in white light, then virtual chromoscopy (NBI), and then an examination with magnification. The examination results are recorded in the scientific protocol separately, and are assessed as a whole. The criteria for visual removal of the formation within healthy tissues are the absence of visible fragments of the formation. The time of complete cessation of capillary bleeding is recorded."

Trial Locations (1)

Unknown

RECRUITING

Evgeny Gorbachev, Moscow

All Listed Sponsors
lead

Pirogov Russian National Research Medical University

OTHER