Clinical trial NCT03520361: Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People
Official title: Comparative Evaluation of the Efficacy of Oral Sulfate Solution (OSS) and 2L Polyethylene Glycol (PEG) With Ascorbic Acid (Asc) for Bowel Preparation of Elderly People: A Multicenter Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Colonoscopy
Bowel preparation
Oral sulfate solution
Polyethylene glycol
Ascorbic acid
Lead sponsor: KangWon National University Hospital
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 198
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: For evaluation of the usefulness of oral sulfate solution (OSS) for bowel preparation of elderly people, investigators compare the efficacy, tolerability and safety between OSS and 2L polyethylene glycol (PEG) with ascorbic acid (Asc).

Detailed description: This study is a multicenter, prospective, randomized parallel arm, investigator initiated trial.

The aim of study is to compare oral sulfate solution (OSS) with 2L polyethylene glycol (PEG) with ascorbic acid (Asc) for bowel preparation in elderly people.

99 participants will be enrolled in each group (198 in total). The primary outcome is the efficacy of bowel preparation. Secondary outcomes are tolerability, satisfaction, and safety.

Eligibility criteria: Inclusion Criteria:

* Colonoscopy examinee aged 65-80
* Examinee agree with informed consent

Exclusion Criteria:

* Cognitive disorder, mental retardation
* Bowel obstruction
* Severe constipation (\<3 bowel movements per week with or without regular or intermittent laxatives)
* History of bowel surgery
* Liver cirrhosis or ascites
* Heart failure, cardiac disease (ischemic heart disease or coronary artery disease within the last 6 months)
* Inflammatory bowel disease
* Pregnancy, lactating woman
* Renal impairment or history of impaired renal function
* History of hypersensitivity reaction to bowel preparation

Primary outcomes:
measure: Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS)
timeFrame: 3 months
Secondary outcomes:
measure: Subject's satisfaction based on the 10-point visual analog scale
timeFrame: 3 months
measure: Number of subjects who have a difficulty taking solution based on the 5-grade scale
timeFrame: 3 months
measure: Taste of recommended bowel preparation agent based on the 5-grade scale
timeFrame: 3 months
measure: Number of subjects who have a willingness to repeat the same regimen
timeFrame: 3 months
measure: Rate of subjects with nausea
timeFrame: 3 months
measure: Rate of subjects with vomiting
timeFrame: 3 months
measure: Rate of subjects with abdominal pain
timeFrame: 3 months
measure: Rate of subjects with abdominal distention
timeFrame: 3 months
measure: Rate of subjects with thirst
timeFrame: 3 months
measure: Rate of subjects with dizziness
timeFrame: 3 months
measure: Rate of subjects with paresthesia
timeFrame: 3 months
measure: Sodium level in mmol/L
timeFrame: an average of 1 year
measure: Potassium level in mmol/L
timeFrame: 3 months
measure: Chloride level in mmol/L
timeFrame: 3 months
measure: Magnesium level in mg/dL
timeFrame: 3 months
measure: Phosphorus level in mg/dL
timeFrame: 3 months
measure: Calcium level in mg/dL
timeFrame: 3 months
measure: Blood urea nitrogen level in mg/dL
timeFrame: 3 months
measure: Creatinine level in mg/dL
timeFrame: 3 months
measure: Serum osmolarity in mmol/kg
timeFrame: 3 months
measure: Urine osmolarity in mmol/L
timeFrame: 3 months
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Gangwon-do
Study officials:
affiliation: KangWon National University Hospital
name: Sung Chul Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: