Colonoscopy
Conditions
Keywords
Colonoscopy, Bowel preparation, Oral sulfate solution, Polyethylene glycol, Ascorbic acid
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.
Interventions
Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g
DRUG2L PEG/Asc
Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g
Sponsors
KangWon National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
Single Blind (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS) | 3 months | The BBPS assesses cleanliness of 3 segments of the colon (ascending, transverse, and descending colon), and the total is a 10-point scale (0-9) that grades each segment of the colon from 0 to 3. In this study, adequate bowel preparation is defined as a total score 6 points or higher and individual score of 2 points or higher in each segment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's satisfaction based on the 10-point visual analog scale | 3 months | The 10-point scale from 0 to 10 |
| Number of subjects who have a difficulty taking solution based on the 5-grade scale | 3 months | The 5-grade scale: very easy, easy, moderate, hard, and very hard |
| Taste of recommended bowel preparation agent based on the 5-grade scale | 3 months | The 5-grade scale: very good, good, neutral, bad, and very bad |
| Number of subjects who have a willingness to repeat the same regimen | 3 months | using questionnaires: yes, no |
| Rate of subjects with nausea | 3 months | using questionnaires: yes, no |
| Rate of subjects with abdominal pain | 3 months | using questionnaires: yes, no |
| Rate of subjects with vomiting | 3 months | using questionnaires: yes, no |
| Rate of subjects with abdominal distention | 3 months | using questionnaires: yes, no |
| Rate of subjects with thirst | 3 months | using questionnaires: yes, no |
| Rate of subjects with dizziness | 3 months | using questionnaires: yes, no |
| Urine osmolarity in mmol/L | 3 months | change in osmolarity values before and after bowel preparation |
| Sodium level in mmol/L | an average of 1 year | change in electrolyte values before and after bowel preparation |
| Potassium level in mmol/L | 3 months | change in electrolyte values before and after bowel preparation |
| Chloride level in mmol/L | 3 months | change in electrolyte values before and after bowel preparation |
| Magnesium level in mg/dL | 3 months | change in electrolyte values before and after bowel preparation |
| Phosphorus level in mg/dL | 3 months | change in electrolyte values before and after bowel preparation |
| Calcium level in mg/dL | 3 months | change in electrolyte values before and after bowel preparation |
| Blood urea nitrogen level in mg/dL | 3 months | change in electrolyte values before and after bowel preparation |
| Creatinine level in mg/dL | 3 months | change in electrolyte values before and after bowel preparation |
| Serum osmolarity in mmol/kg | 3 months | change in osmolarity values before and after bowel preparation |
| Rate of subjects with paresthesia | 3 months | using questionnaires: yes, no |
Countries
South Korea
Outcome results
None listed