Clinical trial NCT03248726: Comparing Single-dose Low-volume PEG Plus Bisacodyl vs. Split-dose PEG for Bowel Preparation in Morning Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation
Keywords: Polyethylene Glycol
Bisacodyl
Colonoscopy
Bowel preparation
Ottawa bowel preparation scale
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: The Ottawa Bowel Preparation Scale
timeFrame: Within 24 hours after colonoscopy
Secondary outcomes:
measure: Life disturbance
timeFrame: 30 minutes before patient receive colonoscopy
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wanfang Hospital
Study officials:
affiliation: Gastroenterology division, Internal Medicine Department, Wanfang Hospital
name: Wei-Cheng Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: