Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision 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
- 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 group versus no ileostomy group after total mesorectal excision for rectal cancer.
详细描述
So far, there are no relevant reports on ghost ileostomy among the Asian population, and all studies are small sample studies.In the past decades, with the advent of circular stapling devices, many middle and low rectal cancers have chosen new sphincter-saving procedures (such as ISR and Ta TME). Nevertheless, when the incidence rate of AL remains high, is diverting ileostomy applicable? Is ghost ileostomy applicable to rectal cancer in the context of new surgical procedures such as pelvic floor reconstruction, perineal drainage, anastomotic reinforcement and robotic surgery? Is this delayed stoma safe and feasible with the increase of preoperative neoadjuvant therapy? Therefore, our study proposes to summarize the review of the complications of GI and no stoma to explore the safety and effectiveness of GI in clinical practice.
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 rectal cancer.
- •age ≥18 years and ≤80 years.
- •intraoperative ghost ileostomy or no stoma was performed.
排除标准
- •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 before 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 total mesorectal excision 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)
- The number of hospitalizations(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)
- Total hospitalization costs(Through study completion, an average of 1 year)
研究者
fan li
Prof.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University