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Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy

Phase 4
Conditions
Colonic Polyp
Colon Adenoma
Interventions
Drug: CleanViewAL
Registration Number
NCT04758156
Lead Sponsor
Seoul National University Hospital
Brief Summary

Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy

study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University )

patient inclusion criteria

- aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care
Exclusion Criteria
  • previous history of significant gastrointestinal surgeries (except for appendectomy)
  • known or clinically suspicious Inflammatory bowel disease patients
  • known or suspected ileus/ GI obstruction
  • previous history of major cancer or currently on treating cancer
  • Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication
  • severe cognitive impairment / dementia / confusion state
  • past history within the last 12 months or current episode of severe constipation severe constipation
  • Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation)
  • women who are pregnant or lactating
  • known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency
  • those who were allergic to any preparation components.
  • those who, in the opinion of the investigator, should not be included in the study for any reason

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CleanViewALCleanViewAL1L polyethylene glycol+ascorbic acid split dose
SUPREPSUPREPOral sulfate solutiom
Primary Outcome Measures
NameTimeMethod
Boston Bowel Preparation Scale (BBPS)at the time of colonoscopy procedure

Bowel cleansing score

Secondary Outcome Measures
NameTimeMethod
questionnaire gathered for Tolerability, compliance, satisfactionon the 1 day of colonoscopy via questionnaire

information gathered via questionnaire

Trial Locations

Locations (1)

Seoul national university hospital

🇰🇷

Seoul, Korea, Republic of

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