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临床试验/TCTR20230411007
TCTR20230411007已完成3 期

Combination Lubiprostone and Split-Dose PEG-ELS Vs Split-Dose PEG-ELS alone for bowel preparation before colonoscopy in constipated patients: A prospective, endoscopist-blinded, randomized controlled trial

Dr. Kawin Tangvoraphonkchai0 个研究点目标入组 68 人开始时间: 2023年4月11日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
68

研究概览

简要总结

The rate of adequate bowel cleaning was comparable between PEG-ELS plus Lubiprostone group and PEG-ELS alone group (50% vs 52.9% respectively p-value 0.81) with relative risk 1.13 (95% CI 0.43 - 2.91). There was no significant difference in adenoma detection rate (41.2 % vs 35.3 % respectively, p-value 0.62), adverse events, acceptance, compliance, and patient satisfaction between the 2 groups.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • •18-75 years of age patients that are indicated for colonoscopy with constipation (Compatible with ROME IV diagnostic criteria for chronic constipation or history of Bristol stool form scale 1-2).

排除标准

  • •Suspected bowel obstruction or perforation, uncontrolled condition e.g. congestive heart failure, unstable angina pectoris, unstable hypertension, cardiac arrhythmia, liver failure, acute kidney injury, uncontrolled blood glucose, hypo-hyperthyroid state, cannot stop warfarin for 3 days, cannot stop antiplatelet for 7 days, history of colectomy, pregnancy or breastfeeding, history of drug allergy for PEG-ELS or Lubiprostone, coagulopathy(INR > 1.5), and thrombocytopenia (< 50000 /ul).

研究者

发起方
Dr. Kawin Tangvoraphonkchai

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