跳至主要内容
临床试验/NCT05912114
NCT05912114招募中不适用

Effectiveness of 1L Mannitol Versus 1L Polyethylene Glycol Electrolyte Dispersion as a Salve for Patients With Inadequate Bowel Preparation: a Randomized Controlled Clinical Trial

Ningbo No. 1 Hospital1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2023年6月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
134
试验地点
1
主要终点
Bowel cleanliness

研究概览

简要总结

For patients with inadequate bowel preparation, current guidelines recommend either remedial measures or rescheduling the endoscopy, but previous surveys have found that approximately 30% of patients do not follow medical advice to reschedule the examination if it is rescheduled, while those who take remedial measures on the same day are more compliant, so remedial measures may be a better option than rescheduling the examination. As for the remedy regimen, it has been demonstrated that oral PEG is superior to the enema regimen in terms of bowel cleansing, but PEG is very resistant to be taken by most patients due to its poor taste and the larger doses required, resulting in poor bowel preparation and poor compliance. In contrast, oral mannitol has the advantages of small dose and good taste, and patient compliance may be higher.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (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

入选标准

  • Patients aged 18-75 years with a pre-first colonoscopy bowel cleanliness of less than 2 points in any segment of the bowel.

排除标准

  • (1) Pregnant women. (2) History of colorectal surgery. (3) Patients with acute exacerbation of inflammatory bowel disease. (4) Patients with severe medical conditions that make them unsuitable for colonoscopy.
  • (5) Patients with known allergy to mannitol/PEG. (6) Patients who refuse to sign the informed consent form.

研究组 & 干预措施

Mannitol

Experimental

Use of oral 1L Mannitol for remediation of intestinal uncleanliness

干预措施: Mannitol (Drug)

Polyethylene glycol electrolyte

Active Comparator

Use of oral 1L PEG for remediation of intestinal uncleanliness

干预措施: Polyethylene glycol electrolyte (Drug)

结局指标

主要结局

Bowel cleanliness

时间窗: 1 hour

The BBPS scoring method, defined as a score of ≥2 for each bowel segment, was used to consider the preparation adequate.

次要结局

  • Patients' feelings(1 hour)

研究者

发起方
Ningbo No. 1 Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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