Randomized controlled trial to compare low dose oral sulfate solution and polyethylene glycol in adults

A multicenter randomized single-blind controlled trial comparing oral sulfate solution with 4-L polyethylene glycol given by split-dose as preparation for elective colonoscopy in adult outpatients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001651

Enrollment

210

Registered

2015-10-07

Start date

2015-11-18

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : (1) OSS group: ? Participants taken low fiber diet for 3 days before the exam, take clear liquid diet on the day before the exam, and then, fast after 6 P.M. on the day before the exam. ? Half

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult (aged 19-65) outpatient or screening recipients who undergo colonoscopy for a range of symptoms and treatments. 2) Those who give informed consent to the study

Exclusion criteria

Exclusion criteria: 1) previous colectomy 2) severe constipation, idiopathic colonic pseudoobstruction 3) pregnancy, lactation, and possible pregnancy 4) acute exacerbation of inflammatory bowel disese 5) uncontrolled chronic medical illnesses which hinder trial participation such as major cardiac, renal, metabolic and psychologic disorder 6) acute or chronic acute or chronic azotemia (glomerular filtration rate <30mL/min/1.73m2) or clinical evidence of dehydration 7) allergy or suspicious allergy to polyethylene glycol or oral sulfate solution

Design outcomes

Primary

Measure	Time frame
degree of bowel prepration	—

Secondary

Measure	Time frame
acceptability to bowel preparation agent;satisfaction to bowel preparation agent;Safety (nausea, vomiting, abdominal pain and cramps, bloating, anal irritation and any other adevese events during additional bowel preparation)	—

Countries

Korea, Republic of

Contacts

Public ContactHyo-Joon Yang

Kangbuk Samsung Medical Center

hyojoonyang@gmail.com

Outcome results