A Multicenter, Prospective, Randomized Controlled Clinical Trial of the Effect of Conformal Sphincter-preservation Operation Versus Intersphincteric Resection on Postoperative Anal Function in Patients With Low Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- Wexner incontinence score
研究概览
简要总结
In this clinical trial, the investigators compared anal function, genitourinary function, quality of life, perioperative safety, and oncological prognosis after CSPO for patients with low rectal cancer, using ISR as a control, to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical approaches for patients with low rectal cancer.
详细描述
The CSPO surgical approach is a series of targeted improvements designed primarily on the basis of analyzing the causes of poor postoperative function of the ISR, while building on research on the ultrastructure of the pelvic floor anal canal. For these reasons, the investigators designed the present study to compare anal function, quality of life, perioperative safety, and oncologic prognosis after CSPO for patients with low rectal cancer, using ISR surgery as a control, and to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical modalities for patients with low rectal cancer.
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
- •Age: 18-75 years;
- •Pathologically confirmed: moderately & well-differentiated rectal cancer;
- •Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;
- •Tumor diameter: ≤3cm or <1/3 bowel circumference;
- •Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
- •Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
- •ASA score: I-III and ECOG score: 0-1;
- •Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
- •Normal preoperative anal function: Wexner score <10, LARS score <20;
- •Agree to participate in the clinical trial and sign an informed consent form.
排除标准
- •Combination of synchronous or metachronous (within 5 years) malignant tumors;
- •Combined distant metastasis of the tumor;
- •Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;
- •Combined psychiatric disorders that do not allow them to understand and participate in the study;
- •Combined systemic diseases that cannot tolerate surgery;
- •Women who are pregnant or breastfeeding;
- •Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.
研究组 & 干预措施
Group A (experimental group): CSPO group
The distal rectum is isolated to the entrance of the internal and external sphincter space, and then an oblique resection line is designed under direct vision according to the tumor site and shape, ensuring that the distal and lateral margins are not less than 1 cm, and preserving the contralateral dentate line and intestinal wall as much as possible, and completing the anastomosis manually or with instruments.
干预措施: CSPO (Procedure)
Group B (control group): ISR group
Partial, subtotal, or complete resection of the internal sphincter and/or a portion of the longitudinal rectal muscle, expansion of the distal rectal incision margin into the anal canal or to the anal verge, and completion of colorectal-anal anastomosis manually or instrumentally
干预措施: ISR (Procedure)
结局指标
主要结局
Wexner incontinence score
时间窗: 12 months after protective stoma closure
The scale was totaled from 0 to 20, with higher scores indicating more severe disease and poorer anal function.
次要结局
- LARS scoreIncontinence Score(12 months after protective stoma closure)
- Quality of Life Questionaire-Core 30(12 months after radical resection of rectal cancer and protective stoma closure)
- Overall survival(3 years)
- Clavien-Dindo complication grading(perioperative period)