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

NCT03248726 | Completed

• 1 other identifier: N201610042
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bowel Preparation

Keywords

Polyethylene Glycol; Bisacodyl; Colonoscopy; Bowel preparation; Ottawa bowel preparation scale

Outcome Measures

Primary Outcomes (1)

• The Ottawa Bowel Preparation Scale

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

  Within 24 hours after colonoscopy

Secondary Outcomes (1)

• Life disturbance

  30 minutes before patient receive colonoscopy

Study Arms (2)

Polyethylene glycol and bisacodyl

EXPERIMENTAL

In order to decrease the dose and frequency of polyethylene glycol, we added bisacodyl at the night before examination to facilitate the action of polyethylene glycol given solely in the morning of examination.

Drug: Polyethylene glycol and bisacodyl

Split-dose polyethylene glycol

ACTIVE COMPARATOR

The standard regimen of polyethylene glycol was used in this group. The participant of this arm receives polyethylene glycol in the evening before examination and the morning of examination .

Drug: Split-dose polyethylene glycol

Interventions

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.

Also known as: Dulcolax®, Klean-prep®

Polyethylene glycol and bisacodyl

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.

Also known as: Klean-prep®

Split-dose polyethylene glycol

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Wanfang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Interventions

Polyethylene Glycols; Bisacodyl; klean prep

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Wei-Cheng Huang, Bachelor

  Gastroenterology division, Internal Medicine Department, Wanfang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: August 14, 2017
• Study Start: July 14, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)