Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 616
- 试验地点
- 1
- 主要终点
- The morbidity of anastomotic leakage.
研究概览
简要总结
This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.
详细描述
Anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. However, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. Recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. Hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged older than 18 years and younger than 85 years.
- •Primary rectal adenocarcinoma confirmed by preoperative pathology result.
- •Expected curative resection via total mesorectal excision procedure.
- •American Society of Anesthesiologists (ASA) class I, II, or III.
- •Written informed consent.
排除标准
- •Pregnant or breastfeeding women.
- •Severe mental disorder or language communication disorder.
- •Hartmann surgery or colostomy is performed intraoperatively.
- •Interrupted of surgery for more than 30 minutes due to any cause.
- •Malignant tumors with other organs
研究组 & 干预措施
Control
Whether the patients in the control arm will receive a temporary ileostomy depends on surgeons' experience.
Intervention
Whether the patients in the intervention arm will receive a temporary ileostomy depends on the risk of anastomotic leakage calculated by the artificial intelligence algorithm.
干预措施: Artificial intelligence algorithm (Other)
结局指标
主要结局
The morbidity of anastomotic leakage.
时间窗: 30 days
The diagnosis of anastomotic leakage is determined when the passage of fecal material from pelvic drainage tube or the water-soluble contrast agent enema and extra-rectal imaging. Alternatively, anastomotic leakage can be diagnosed when the integrity of the anastomosis is interrupted or the appearance of pelvic abscess next to the anastomosis by computerized tomography (CT) examination or secondary surgical exploration.
The rate of temporary ileostomy.
时间窗: Intraoperative period
次要结局
未报告次要终点
研究者
Jichao Qin
Professor
Tongji Hospital