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

NCT ID: NCT03248726

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2019-09-30

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.

Detailed 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.

Conditions

Bowel Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Polyethylene glycol and bisacodyl

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.

Group Type: EXPERIMENTAL

Polyethylene glycol and bisacodyl

Intervention Type: 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.

Split-dose polyethylene glycol

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 .

Group Type: ACTIVE_COMPARATOR

Split-dose polyethylene glycol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Dulcolax®; Klean-prep®; Klean-prep®

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Cheng Huang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology division, Internal Medicine Department, Wanfang Hospital

Locations

Wanfang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N201610042

Identifier Type: -

Identifier Source: org_study_id