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

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

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).

Study Overview

• Status: Unknown
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Oral sulfate solution (OSS); Drug: 2L PEG/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.

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 24289
      • Kangwon National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oral sulfate solution (OSS) taking group; 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); Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g; Other Names: Suclear® solution (Phambio Korea, Seoul, Korea)
ACTIVE_COMPARATOR: 2L PEG/Asc taking group; 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; 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; Other Names: Haprep® powder (Phambio Korea, Seoul, Korea)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KangWon National University Hospital
• Investigators: Principal Investigator: Sung Chul Park, MD, PhD, Kangwon National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2017
• Primary Completion (ANTICIPATED): April 30, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (ACTUAL): May 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Colonoscopy; Ascorbic acid; Polyethylene glycol; Bowel preparation; Oral sulfate solution
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 2017-03-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No