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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07371273

Enrollment

100

Registered

2026-01-27

Start date

2026-01-07

Completion date

2029-12-30

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief 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.

Interventions

PROCEDUREQuadrant-based Intersphincteric Resection

Q-ISR (Quadrant-based 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Wexner score	3years
LARS scores	3years
disease-free survival	5years

Countries

China

Contacts

CONTACTDawei Li

li_dawei@fudan.edu.cn+86-021-64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026