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NCT07371273
Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR
Phase 2 trial testing Quadrant-based Intersphincteric Resection in Colorectal Cancer in 100 participants. Currently enrolling.
7 January 2029
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 7 January 2026 |
| Primary completion | 7 January 2029 |
| Estimated completion | 30 December 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Quadrant-based Intersphincteric Resection
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07371273
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07371273 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 27 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07371273.
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