Comparison of efficacy and safety of 1-L polyethylene glycol plus ascorbic acid for bowel preparation: a randomized multicenter clinical trial

Not Applicable

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, NEC

• Registration Number: KCT0008442
• Lead Sponsor: The Catholic University of Korea, St. Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

A patient who is deemed to require an endoscopy due to complaints of digestive symptoms and meets all of the following selection criteria:
(1) Adult males and females between the ages of 19 and 74
(2) Individuals scheduled to undergo upper/lower gastrointestinal endoscopy
(3) Body Mass Index (BMI) = 30
(4) Voluntarily consents to participate in this clinical trial and signs the consent form.

Exclusion Criteria

Individuals who meet any of the following criteria:
(1) History of the following surgeries, medical conditions, or comorbidities:
- Dehydration
-Colorectal resection
- Gastrointestinal obstruction (intestinal obstruction, gastrointestinal obstruction, etc.), perforation, or gastric outlet obstruction (gastroparesis, etc.)
- Inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.) or toxic megacolon
- Regular or ongoing use of laxatives or stool softeners, or severe constipation requiring physical intervention (e.g. more than 3 bowel movements per week)
- Severe cardiac disease (NYHA class 3,4 heart failure, acute coronary artery disease within 24 weeks prior to screening, clinically significant arrhythmias, hypertrophic obstructive cardiomyopathy, valvular heart disease, aortic disease, and peripheral vascular disease)
- History of cardiac arrest
- Blood coagulation disorders
- Severe chronic kidney disease (eGFR or CrCl < 30, gross hematuria)
- Active cancer patients at screening
- Major psychiatric disorders (depression, bipolar disorder, etc.) or history of drug/alcohol abuse
- Patients with loss of consciousness
(2) individuals with the following abnormal test results:
- Creatinine >= 2 x upper limit of normal
- AST or ALT >= 3 x upper limit of normal
(3) Pregnant or breastfeeding women, or individuals planning to become pregnant during the screening period
(4) Glucose-6-phosphate dehydrogenase deficiency patients
(5) Patients with confirmed or suspected phenylketonuria
(6) Patients with hypersensitivity or allergy to any component of the investigational product during the clinical trial
(7) Individuals requiring concomitant use of prohibited drugs during the clinical trial period
(8) Individuals who have received investigational drugs or medical devices in other clinical trials
(9) Other individuals who are deemed unsuitable for participation in the study by the investigator.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects evaluated as successful cleansing on the Harefield Cleansing Scale (HCS)

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects evaluated as high quality cleansing and the average score for each of the 5 segments on the Harefield Cleansing Scale (HCS);The proportion of subjects evaluated as successful cleansing on the Boston bowel preparation scale (BBPS);The proportion of subjects evaluated as high quality cleansing and the average score for each of the 3 segments on the Boston bowel preparation scale (BBPS);The proportion of subjects in whom one or more polyps/adenomas were detected in the entire colon and the ascending colon.;Adherence for investigational product;Satisfaction assessment;Gastric food/fluid retention;Treatment-emergent adverse event (TEAE)