NCT04776421Unknown不适用
A Prospective Registration Study on Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery in Middle and Low Rectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- comprehensive complication index
研究概览
简要总结
Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Necessary conditions: meet one of the following conditions
- •Difficult pelvis: narrow pelvis (diameter of ischial tuberosity <10 cm, diameter of ischial spine <12 cm) 13 or BMI≥30kg/m2 or tumor diameter≥5cm
- •To receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or ESD
- •The anastomosis is below the level of the levator ani muscle: such as ISR, TaTME surgery, etc.
- •Other conditions:
- •Age: 18 to 75 years old, male or female;
- •Preoperative biopsy pathological diagnosis of rectal adenocarcinoma;
- •Received MRI evaluation before surgery, and the distance between the lower edge of the tumor and the anal edge is no more than 10cm;
- •The clinical stage is T1-3N0-2M0;
- •Undertake elective laparoscopic TME for colon-rectal or colon-anal anastomosis
- •ECOG score 0-2;
- •Heart, lung, liver, and kidney functions can tolerate surgery;
- •Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.
排除标准
- •Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- •Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- •Neighboring organs need to be combined with organ removal
- •ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
- •Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
- •Have a history of severe mental illness;
- •Pregnant or lactating women;
- •Those with a history of taking hormone drugs;
- •Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
结局指标
主要结局
comprehensive complication index
时间窗: 1 year
comprehensive complication index, CCI
次要结局
- Stoma-related complications(3 months)
- Complications related to ileostomy reversal(three months after ileostomy reversal)
- Overall Survival(three years after the operation)
- Postoperative complications(1 year)
- Incidence of anastomotic leakage(1 year)
- Incidence of anastomotic stenosis(1 year)
研究者
Quan Wang
Head of Department
The First Hospital of Jilin University
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