Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative bloody stool
研究概览
简要总结
Currently, hemorrhage remains the most common postoperative complication in patients with colon polyps, with an incidence of approximately 1.5%. The main reasons for postoperative hemorrhage are: the patient's own condition, the nature of the polyp and the operation. The number of patients treated for colon polyps has increased, postoperative care is confusing, medical resources are wasted, and the time span for postoperative diet recovery is large. However, studies on the effect of postoperative dietary recovery timing on postoperative polyp bleeding are rare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
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 18-75, no gender restrictions,
- •Patients with colonic polyps identified by colonoscopy and requiring endoscopic treatment,
- •Polyp size 0.5cm-2cm,
- •Patients agreed to enroll and signed a written informed consent,
- •Adherence is good and agrees to be treated and evaluated as required by the study protocol.
排除标准
- •Patients with contraindications to endoscopic treatment of colonic polyps, including platelets ≤50×109/L, prothrombin time prolonged by 4 seconds or more, and INR≥2.0,
- •Patients with severe heart, brain, lung, blood system diseases, uremia, connective tissue disease,
- •Patients requiring treatment with NSAIDs, aspirin, glucocorticoids, or clopidogrel within the first 7 days of the study,
- •During the course of the study, due to other concomitant/complications, patients who need to use drugs that affect the efficacy of the trial, including various anticoagulants, antiplatelet drugs and hemostatic drugs,
- •Alcoholics, drug addicts or those with uncontrollable neuropsychiatric diseases and others who are not suitable for participating in the trial,
- •Pregnant, breastfeeding women, or women in childbearing age who wish to become pregnant,
- •Patients with malignant tumor of digestive system,
- •Other circumstances in which the investigator believes that the patient should not participate in this trial
结局指标
主要结局
Postoperative bloody stool
时间窗: up to 2 weeks
Postoperative massive hemorrhage: if the amount of blood in stool exceeds 400ml within 1 hour to 14 days after operation, or the hemoglobin decreases \>2g/dl Ordinary hemorrhage: the amount of blood in stool does not meet the above standards
次要结局
未报告次要终点