NCT03989791Unknown不适用
The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 406
- 主要终点
- postoperative adverse event rate
研究概览
简要总结
There is no evidence to prove the impact of post-procedural diet on post-polypectomy bleeding (PPB) or delayed perforation. No relevant study has been conducted and it is yet to be determined if absolute diet is necessary for post-polypectomy patients, and the comparison between normal diet and absolute diet also remains unclear. Therefore, we carried out this randomized controlled study to evaluate and compare tthe clinical effect of different diets on post-polypectomy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18-75 patient with initial diagnosis of colorectal polyp by colonoscopy;
- •The maximum size of polyp is more than 20mm;
- •The patients underwent single ESD procedure for the polyp and agreed to participate this trial.
排除标准
- •Uncontrollable hypertension or diabetes；
- •Severe comorbidities such as cancer and organ failure etc；
- •Patients who were pregnant;
- •Patients had anticoagulants during perioperative period;
- •Patients with poor compliance. -
研究组 & 干预措施
Absolute diet
Active Comparator
干预措施: absolute diet (Dietary Supplement)
Normal diet
Experimental
干预措施: normal diet (Dietary Supplement)
结局指标
主要结局
postoperative adverse event rate
时间窗: 14-day after polypectomy
Postoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation.
次要结局
- length of stay(14-day after polypectomy)
- hospitalization cost(14-day after polypectomy)
研究者
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