Clinical Trial

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

Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07371273
Lead Sponsor Fudan University
Conditions Colorectal Cancer
Enrollment 100 participants
Start Date 2026-01-07
Primary Completion 2029-01-07 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-27