跳至主要内容
临床试验/NCT02643316
NCT02643316已完成不适用

Morning-Only 4 Liter Polyethylene Glycol vs. Split Dose for Afternoon Colonoscopies, a Randomized Endoscopist-Blinded Prospective Study

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Quality of preparation (Ottawa score)

研究概览

简要总结

Comparison of quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy procedure.

详细描述

The aim of colorectal cancer screening is to reduce mortality. This can be effectively achieved by colonoscopy with direct visualization of the entire colon to detect preneoplastic lesions such as adenomatous polyps. Bowel preparation quality is critical for the accuracy of colonoscopy, time required to complete the procedure and its success. On the other hand, poor quality of bowel preparation was shown to be associated with a lower adenoma detection rate. Prior studies have shown that time of colonoscopy is one of the major factors influencing bowel preparation quality with the afternoon colonoscopies being notable for a high failure rate. This failure rate is related to poor bowel preparation quality. Given that, the number of afternoon colonoscopies performed is still high due to the increased need for colonoscopies. Therefore, it is suggested that improving the bowel preparation quality can reduce failure rate of afternoon colonoscopies. Several studies on split-dose bowel preparation have shown that it is superior to the conventional day-before regimen, in terms of preparation quality and patient's tolerability. Another study on split-dose bowel preparation also showed that it is associated with a better adenoma detection rate, better polyp detection rate and colonoscopy completion rate. There also have been few studies comparing same day dose vs. day-before for afternoon colonoscopies and showed that same day was superior to day before.There is no data comparing quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split-dose preparation for an afternoon colonoscopy.

Using a 4L PEG-ELS solution, the investigators aim to evaluate the efficacy and patient's tolerability for the same day versus split-dose regimen.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients above 18 years of age undergoing elective outpatient colonoscopy at CCF Florida who are scheduled for an afternoon colonoscopy procedure. All patients must have been prescribed a 4 L PEG based bowel preparation.

排除标准

  • Patients who had prior Colectomy or colon resection surgery.
  • Patients with confirmed diagnosis of impaired GI motility.
  • Chronic nausea or vomiting.
  • Severe constipation (=/<1 bowel movement per week).
  • Breast feeding.
  • Patients taking drugs which are known to influence GI motility.
  • Hospital inpatients.

研究组 & 干预措施

Same day 4 L preparation of PEG

Active Comparator

Receive 1 gallon (4 L) of Polyethylene Glycol (PEG) preparation on the morning of the colonoscopy.

干预措施: Same day 4 L preparation (Polyethylene Glycol) (Drug)

Split dose 4 L preparation of of the PEG

Active Comparator

Receive the split-dose regimen. Will take half (2 L) of the PEG preparation the evening before colonoscopy and half (2 L) of the PEG preparation on the morning of the procedure.

干预措施: Split dose 4 L preparation (Polyethylene Glycol) (Drug)

结局指标

主要结局

Quality of preparation (Ottawa score)

时间窗: During the colonoscopy

The quality of bowel preparation will be assessed for the 2 groups at the time of the colonoscopy using the Ottawa score for quality of preparation.

次要结局

  • Patient satisfaction with the bowel preparation (questionnaire).(Before the colonoscopy procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Castro

Staff Physician

The Cleveland Clinic

研究点 (1)

Loading locations...

相似试验

Morning-Only 4 L PEG vs Split Dose Prep for... | 临床试验