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

Not Applicable

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: Polyethylene glycol and bisacodyl; Drug: Split-dose polyethylene glycol

• Registration Number: NCT03248726
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Study First Submitted: 2017-05-31
• Study Start: 2017-07-14
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyethylene glycol and bisacodyl	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.
Split-dose polyethylene glycol	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 .

Primary Outcome Measures

Name	Time	Method
The Ottawa Bowel Preparation Scale	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 Outcome Measures

Name	Time	Method
Life disturbance	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.

Trial Locations

Locations (1)

Wanfang Hospital; 🇨🇳 Taipei, Taiwan