Comparing quadrant-based, subtotal, and total intersphincteric resections for ultra-low rectal cancer
Official title: Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR
Run by Fudan University · NCT07371273 · Data updated 2026-11-12
This compares a quadrant-tailored intersphincteric resection to subtotal and total ISR to see if it preserves anal function without compromising cancer control in people with ultra-low rectal cancer who are candidates for sphincter-preserving surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | January 7, 2029 |
| Study ends | December 30, 2029 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07371273 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with ultra-low rectal cancer whose tumor edge lies 1.5–2.0 cm from the dentate line, tumor length <3 cm, less than one-third circumferential involvement, good preoperative anal function, ASA score ≤3, and no distant metastasis.
✕Probably not a fit
Patients with distant metastases, undifferentiated or mucinous histology, tumors infiltrating the intersphincteric space, or larger/more circumferential tumors are unlikely to benefit from the quadrant-based approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional comparison enrolls patients with ultra-low rectal cancer undergoing sphincter-preserving surgery and assigns them to quadrant-based ISR (Q-ISR), traditional subtotal ISR (Sub-ISR), or total ISR (t-ISR). Short-term endpoints focus on perioperative safety measures such as operative time, blood loss, length of stay, and postoperative complications including Clavien-Dindo grade ≥II and anastomotic issues. Long-term endpoints evaluate anorectal function after stoma closure using LARS and Wexner scores and oncologic outcomes including R0 resection rates, recurrence patterns, and survival. The study is conducted at Fudan University Shanghai Cancer Center and targets tumors that are small, ultra-low, and not invading the intersphincteric plane.
Why it matters
Potential benefit: If successful, the quadrant-tailored approach could better preserve anal function while maintaining tumor control and reduce the likelihood of permanent stoma.
How similar studies have gone: Conventional and subtotal ISR have prior clinical data showing feasible oncologic outcomes but variable functional recovery, while the quadrant-based Q-ISR approach is relatively novel with limited published evidence to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * (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. Exclusion Criteria: * (1) Presence of distant metastasis. (2) Undifferentiated carcinoma or mucinous adenocarcinoma.
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting
Study contacts
- Study coordinator: Dawei Li
- Email: li_dawei@fudan.edu.cn
- Phone: +86-021-64175590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.