Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation

National Cancer Center (NCC)

Status and phase: Completed; Phase 2

Conditions: Polyethylene Glycol With Ascorbic Acid; Sodium Picosulfate and Magnesium Citrate; Bowel Preparation

Treatments: Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02979223

NCC2016-0166

Details and patient eligibility

About

The aim of this study is to compare the efficacy depending on the order of the sequential combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic acid for bowel preparation.

The investigators designed this study as a phase II prospective randomized parallel arm clinical trial. 71 participant will be enrolled in each group (142 in total).

The primary outcome is the efficacy of bowel preparation. secondary outcomes are tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.

Enrollment: 142 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who agreed to participate in this study

Exclusion criteria

• pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate < 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing electrolyte disturbances, symptomatic congestive heart failure, recent (within < 6 months) symptomatic ischemic heart disease (unstable angina or myocardial infarction).

toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria Patients with a history of colon surgery Abdominal operation within 6 months

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

PMC/PEG-Asc

Experimental group

Description:

Picolyte 1 bottle/170cc at one day before colonoscopy, 7 PM. And then, Intake Coolprep 1L at the day of colonoscopy, 5 AM

Treatment:

Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

PEG-Asc/PMC

Active Comparator group

Description:

Intake Coolprep 1L at one day before colonoscopy, 7 PM. And then, Intake Picolyte 1 bottle/170cc at the day of colonoscopy, 5AM

Treatment:

Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid