Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Oral sulfate solution (OSS)
* Drug: 2L PEG/Asc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral sulfate solution (OSS) taking group<br>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. | Drug: Oral sulfate solution (OSS)<br>* Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g<br>* Other names: Suclear® solution (Phambio Korea, Seoul, Korea);|
| Active Comparator: 2L PEG/Asc taking group<br>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. | Drug: 2L PEG/Asc<br>* 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<br>* Other names: Haprep® powder (Phambio Korea, Seoul, Korea);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS) | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's satisfaction based on the 10-point visual analog scale | The 10-point scale from 0 to 10 | 3 months | 
| Number of subjects who have a difficulty taking solution based on the 5-grade scale | The 5-grade scale: very easy, easy, moderate, hard, and very hard | 3 months | 
| Taste of recommended bowel preparation agent based on the 5-grade scale | The 5-grade scale: very good, good, neutral, bad, and very bad | 3 months | 
| Number of subjects who have a willingness to repeat the same regimen | using questionnaires: yes, no | 3 months | 
| Rate of subjects with nausea | using questionnaires: yes, no | 3 months | 
| Rate of subjects with vomiting | using questionnaires: yes, no | 3 months | 
| Rate of subjects with abdominal pain | using questionnaires: yes, no | 3 months | 
| Rate of subjects with abdominal distention | using questionnaires: yes, no | 3 months | 
| Rate of subjects with thirst | using questionnaires: yes, no | 3 months | 
| Rate of subjects with dizziness | using questionnaires: yes, no | 3 months | 
| Rate of subjects with paresthesia | using questionnaires: yes, no | 3 months | 
| Sodium level in mmol/L | change in electrolyte values before and after bowel preparation | an average of 1 year | 
| Potassium level in mmol/L | change in electrolyte values before and after bowel preparation | 3 months | 
| Chloride level in mmol/L | change in electrolyte values before and after bowel preparation | 3 months | 
| Magnesium level in mg/dL | change in electrolyte values before and after bowel preparation | 3 months | 
| Phosphorus level in mg/dL | change in electrolyte values before and after bowel preparation | 3 months | 
| Calcium level in mg/dL | change in electrolyte values before and after bowel preparation | 3 months | 
| Blood urea nitrogen level in mg/dL | change in electrolyte values before and after bowel preparation | 3 months | 
| Creatinine level in mg/dL | change in electrolyte values before and after bowel preparation | 3 months | 
| Serum osmolarity in mmol/kg | change in osmolarity values before and after bowel preparation | 3 months | 
| Urine osmolarity in mmol/L | change in osmolarity values before and after bowel preparation | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Bowel preparation, Oral sulfate solution, Polyethylene glycol, Ascorbic acid