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临床试验/NCT02980562
NCT02980562已完成3 期

Comparison of a Split Dose Bowel Preparation With 2-L Polyethylene Glycol Plus Ascorbic Acid and 1-L Polyethylene Glycol Plus Ascorbic Acid and Bisacodyl Prior to Colonoscopy

Korea University Anam Hospital0 个研究点目标入组 200 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
200
主要终点
The quality of the bowel preparation using preparation scale

研究概览

简要总结

Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg) formulation to determine the quality of bowel cleansing and patient tolerability.

详细描述

  • Study design A single center, randomized, comparative observer-blinded study was performed from May 2015 to September 2015 at the Department of Gastroenterology and Digestive Endoscopy at Korea University Anam Hospital (Seoul, Korea).

In total, 200 outpatients received lower volume 1-L PEG with ascorbic acid plus bisacodyl (1L-PEG/AB) or low volume 2-L PEG with ascorbic acid (2L-PEG/A) in a 1:1 ratio.

At the time of registration, subjects were randomly allocated to either group. They were randomized by a computer-generated list and were provided with written instructions. All patients provided written informed consent.

  • Patients All patients between the ages of 20 and 75 years. Patients were excluded from the analysis if they had known or suspected gastrointestinal obstruction, Ileus, severe heart failure, uncontrolled hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg), severe constipation, clinically significant electrolyte abnormalities, any prior bowel resection, or significant gastroparesis.
  • Bowel preparation In the 2L-PEG/A group, 1 L of PEG containing ascorbic acid was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure.

The 1L-PEG/AB group received 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients between the ages of 20 and 75 years who were scheduled to undergo colonoscopy

排除标准

  • aged more than 75 years.
  • known or suspected gastrointestinal obstruction, Ileus
  • severe heart failure
  • uncontrolled hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg)
  • severe constipation
  • clinically significant electrolyte abnormalities
  • any prior bowel resection, or significant gastroparesis.

研究组 & 干预措施

2L Polyethylene glycols-Asc

Active Comparator

1 L of PEG containing ascorbic acid (PEG A) was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure. All colonoscopies were performed between 9 am and 1 pm.

干预措施: Polyethylene Glycols (Drug)

1L PEG-Asc plus bisacodyl

Active Comparator

10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.

干预措施: Bisacodyl (Drug)

结局指标

主要结局

The quality of the bowel preparation using preparation scale

时间窗: 20 minutes

Preparation scale

次要结局

  • The patient's tolerability(30 minutes before the colonoscopy)

研究者

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

Seung Hun Kang

Fellow

Korea University Anam Hospital

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