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

Taipei Medical University

Status: Completed

Conditions: Bowel Preparation

Treatments: Drug: Polyethylene glycol and bisacodyl; Drug: Split-dose polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT03248726

N201610042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Polyethylene glycol and bisacodyl

Experimental group

Description:

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.

Treatment:

Drug: Polyethylene glycol and bisacodyl

Split-dose polyethylene glycol

Active Comparator group

Description:

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 .

Treatment:

Drug: Split-dose polyethylene glycol