Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection for Rectal Cancer: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
研究概览
简要总结
This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the number of hospitalizations with ghost ileostomy versus conventional loop ileostomy after low anterior resection for rectal cancer.
详细描述
Diverting ileostomy (DI) is a common procedure performed in patients undergoing low anterior resection for rectal cancer to protect the anastomosis and reduce the risk of complications. Although DI remains one of the most common methods used in clinical practice to prevent anastomotic leakage, there is still considerable debate in clinical practice about whether to perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly increased the risk of non-elective readmissions and reinterventions as well as higher total costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia, peristomal abscess, and fistula, etc.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathologically confirmed low to intermediate level rectal cancer, with the lower margin of anastomosis <10cm from the anus.
- •age ≥18 years and ≤80 years.
- •the surgical procedure is anterior rectal resection (LAR).
- •intraoperative virtual or conventional ileostomy was performed.
排除标准
- •BMI >30 kg/m².
- •ASA score >
- •Patients with coexisting complete intestinal obstruction.
- •History of long-term use of immunosuppressive drugs or glucocorticoids.
- •Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade
- •Patients with a history of myocardial infarction or coronary artery surgery within 6 months prior to the procedure.
- •chronic renal failure (requiring dialysis or glomerular filtration rate <30 mL/min).
- •Intraoperative combined multi-organ resection.
- •Combined cirrhosis of the liver.
- •Intraoperative findings of incomplete anastomosis and positive insufflation test.
结局指标
主要结局
Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
时间窗: An average of 1 year from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications
The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
次要结局
- Readmission rates(Through study completion, an average of 1 year)
- Postoperative hospitalization days(Through study completion, an average of 1 year)
- First hospitalization costs(During hospitalization,approximately 7 days)
- The number of hospitalizations(Through study completion, an average of 1 year)
- Duration of bearing the stoma (months)(Through study completion, an average of 1 year)
- Total hospitalization costs(Through study completion, an average of 1 year)
研究者
fan li
Professor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University