Actively Recruiting
Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR
Led by Fudan University · Updated on 2026-01-27
100
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rectal cancer diagnosed by digital rectal examination, colonoscopy, and biopsy
- Tumor located 1.5 to 2.0 cm from the dentate line
- Good anal function before surgery
- Tumor does not infiltrate the intersphincteric space
- Tumor length less than 3 cm and occupies less than one-third of intestinal circumference
- American Society of Anesthesiologists (ASA) score of 3 or less
You will not qualify if you...
- Presence of distant metastasis
- Undifferentiated carcinoma or mucinous adenocarcinoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
D
Dawei Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
1
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