NCT07371273RecruitingPhase 2
Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 7 Jan 2026
- Primary completion date
- 7 Jan 2029
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07371273
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 7 Jan 2026 to the primary completion date, 7 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- (1) Presence of distant metastasis. (2) Undifferentiated carcinoma or mucinous adenocarcinoma.
Who the study is looking for
- (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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.