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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• (1) Rectal cancer diagnosed by digital rectal examination, colonoscopy, and combined biopsy pathology. (2) The distance from the lower edge of the tumor to the dentate line is 1.5-2.0 cm. (3) Good anal function before surgery. (4) The tumor does not infiltrate the intersphincteric space. (5) The tumor length is less than 3 cm, and the proportion of the tumor occupying the intestinal lumen is less than 1/3 of the circumference. (6) American Society of Anesthesiologists (ASA) score is ≤3.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Dawei Li
li_dawei@fudan.edu.cn
+86-021-64175590
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 100
Treatments
Experimental: Q-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.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov