Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People
- Registration Number
- NCT03520361
- Lead Sponsor
- KangWon National University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 198
- Colonoscopy examinee aged 65-80
- Examinee agree with informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral sulfate solution (OSS) taking group Oral sulfate solution (OSS) On the evening before colonoscopy, drink 177ml of OSS (Suclear®) (473ml including water in container), additionally allow another 946 ml of water. On the day of colonoscopy, drink 177ml of OSS (473ml including water in container), additionally allow another 946 ml of water. 2L PEG/Asc taking group 2L PEG/Asc On the evening before colonoscopy, drink 1L of 2L PEG/Asc (Haprep®) solution, additionally allow another 500 ml of water. On the day of colonoscopy, drink 1L of 2L PEG/Asc solution, additionally allow another 500 ml of water.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 vomiting 3 months using questionnaires: yes, no
Rate of subjects with abdominal pain 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
Rate of subjects with paresthesia 3 months using questionnaires: yes, no
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
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
Urine osmolarity in mmol/L 3 months change in osmolarity values before and after bowel preparation
Trial Locations
- Locations (1)
Kangwon National University Hospital
🇰🇷Chuncheon, Gangwon-do, Korea, Republic of