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

Bowel Preparation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248726
• Other study ID #: N201610042
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 (NYHA?or?).

• 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.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• Polyethylene glycol and bisacodyl
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.
• Split-dose polyethylene glycol
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.

Locations

Country	Name	City	State
Taiwan	Wanfang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Life disturbance	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.	30 minutes before patient receive colonoscopy