Comparative Study on the Short- and Long-term Efficacy of Q-ISR, Traditional Sub-ISR, and t-ISR
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Wexner score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(1) Presence of distant metastasis. (2) Undifferentiated carcinoma or mucinous adenocarcinoma.
研究组 & 干预措施
Q-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.
干预措施: Quadrant-based Intersphincteric Resection (Procedure)
结局指标
主要结局
Wexner score
时间窗: 3years
LARS scores
时间窗: 3years
disease-free survival
时间窗: 5years
次要结局
未报告次要终点