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Completed

NCT Number: NCT03248726

Comparing Single-dose Low-volume PEG Plus Bisacodyl vs. Split-dose PEG for Bowel Preparation in Morning Colonoscopy

Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation which makes bowel preparation an important issue. Hence, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.

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Key information

Conditions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wanfang Hospital

Taipei, 116, Taiwan

About this study

Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation. That makes bowel preparation an important issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and safety. However, there are many different adjunctive, dose, timing of administration in PEG preparation. Some may decrease patient tolerability due to large fluid volume, and some may influence patient's life and sleep quality when performing bowel preparation. Here, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20-70 years.
  • Out-patient department ambulatory patient.
  • Patients who have indications to receive colonoscopy.

Exclusion criteria

  • Age is under 20 or over 70
  • Have severe renal impairment (hemodialysis or eGFR<30).
  • Have severe congestive heart failure (NYHAⅢorⅣ).
  • Pregnant or lactating, or women is under oral contraceptive.
  • Have history of bowel obstruction or resection, known or suspected gastroparesis acute gastric/intestinal ulcer, toxic colitis or megacolon
  • Be allergic to polyethylene glycol (PEG) or bisacodyl.
  • Have severe constipation ( ≤ 1 bowel movement per week).
  • Patient who has Phenylketonuria.
  • Refuse to sign consent to the study.

Treatment and study plan

Polyethylene glycol and bisacodyl

Drug

Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination.

Other names: Dulcolax®, Klean-prep®

Split-dose polyethylene glycol

Drug

Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day.

Other names: Klean-prep®

Primary outcomes

  1. The Ottawa Bowel Preparation Scale

    Time frame: Within 24 hours after colonoscopy

    Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as "good preparation".

Secondary outcomes

  1. Life disturbance

    Time frame: 30 minutes before patient receive colonoscopy

    Evaluate patients life disturbance with a questionnaire before performing a colonoscopy. The questionnaire including side effect, sleep quality, interference of life/work, and tendency of same bowel preparation method at next colonoscopy.

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

Comparison of Single-dose (Morning) Low-volume Polyethylene Glycol Plus Bisacodyl Versus Split-dose Polyethylene Glycol for Bowel Preparation Efficacy in Patient Receiving Morning Colonoscopy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2017
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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