NCT05502354Unknown不适用
A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- anastomotic rate
研究概览
简要总结
Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 from 18 to 75 years old
- •male and female
- •primary rectal adenocarcinoma
- •ASA I, II, or III
- •laparoscopic LAR + DST
- •with or without preoperative radio- or chemotherapy
- •no distal metastasis
- •no preoperative bowel obstruction
- •no preventive ileostomy or colostomy
- •patients and their families can understand and are willing to participate in this study and provide written informed consent
排除标准
- •emergency operation
- •preoperative abnormal liver function
- •tatme or ISR procedure (healing process might differ from anterior resection)
- •severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
- •severe perioperative infection unrelated to anastomotic leak
- •patients with serious mental illness
- •pregnant or breastfeeding women
- •patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial
研究组 & 干预措施
patients with TDT removal guided by postoperative CRP trajectory
Experimental
干预措施: removal of transanal drainage tube (Device)
结局指标
主要结局
anastomotic rate
时间窗: 30 days after surgery
anastomotic rate
次要结局
- the grades of anastomotic leak(30 days after surgery)
- rates of diarrhea after transanal drainage tube removal(from transanal drainage tube removal to 30 days after surgery)
- visual analogue scale to assess anal postoperative pain(from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks)
- transanal drainage tube-related adverse events(from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks)
研究者
XIANG ZHANG
Principal Investigator
Qilu Hospital of Shandong University
研究点 (1)
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