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RECRUITING
NCT07371273
PHASE2

Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This comparative study evaluates the short- and long-term outcomes of Quadrant-based Intersphincteric Resection (Q-ISR) versus traditional subtotal ISR (Sub-ISR) and conventional/total ISR (t-ISR) in patients with ultra-low rectal cancer undergoing sphincter-preserving surgery, with short-term endpoints focusing on perioperative safety (operative time, blood loss, length of stay, and postoperative complications such as Clavien-Dindo grade ≥II, anastomotic leakage/stricture, and stoma reversal) and long-term endpoints assessing anorectal function recovery (LARS and Wexner scores after stoma closure) and oncologic efficacy (R0 resection, recurrence patterns, and survival outcomes), aiming to determine whether a quadrant-tailored resection strategy can better balance tumor control with anal function preservation.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-07

Completion Date

2029-12-30

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

PROCEDURE

Quadrant-based Intersphincteric Resection

Q-ISR (Quadrant-based ISR): Based on preoperative precise assessment and rectal endoscopic localization, selective resection of the internal sphincter is performed "by quadrant and quantificationally" according to the extent of lesion involvement, while striving to preserve the uninvolved quadrants and the external sphincter-levator ani complex. This aims to ensure R0 resection margins and oncological safety, while reducing the risk of low anterior resection syndrome (LARS) and accelerating the recovery of bowel control function.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China