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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
198
Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g
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
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
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.
Time frame: 3 months
Subject's satisfaction based on the 10-point visual analog scale
The 10-point scale from 0 to 10
Time frame: 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
Time frame: 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
Time frame: 3 months
Number of subjects who have a willingness to repeat the same regimen
using questionnaires: yes, no
Time frame: 3 months
Rate of subjects with nausea
using questionnaires: yes, no
Time frame: 3 months
Rate of subjects with vomiting
using questionnaires: yes, no
Time frame: 3 months
Rate of subjects with abdominal pain
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using questionnaires: yes, no
Time frame: 3 months
Rate of subjects with abdominal distention
using questionnaires: yes, no
Time frame: 3 months
Rate of subjects with thirst
using questionnaires: yes, no
Time frame: 3 months
Rate of subjects with dizziness
using questionnaires: yes, no
Time frame: 3 months
Rate of subjects with paresthesia
using questionnaires: yes, no
Time frame: 3 months
Sodium level in mmol/L
change in electrolyte values before and after bowel preparation
Time frame: an average of 1 year
Potassium level in mmol/L
change in electrolyte values before and after bowel preparation
Time frame: 3 months
Chloride level in mmol/L
change in electrolyte values before and after bowel preparation
Time frame: 3 months
Magnesium level in mg/dL
change in electrolyte values before and after bowel preparation
Time frame: 3 months
Phosphorus level in mg/dL
change in electrolyte values before and after bowel preparation
Time frame: 3 months
Calcium level in mg/dL
change in electrolyte values before and after bowel preparation
Time frame: 3 months
Blood urea nitrogen level in mg/dL
change in electrolyte values before and after bowel preparation
Time frame: 3 months
Creatinine level in mg/dL
change in electrolyte values before and after bowel preparation
Time frame: 3 months
Serum osmolarity in mmol/kg
change in osmolarity values before and after bowel preparation
Time frame: 3 months
Urine osmolarity in mmol/L
change in osmolarity values before and after bowel preparation
Time frame: 3 months