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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03520361
• Other study ID #: 2017-03-011
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: November 2, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2018
• Source: KangWon National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 198
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Oral sulfate solution (OSS)
Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g
• 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

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National University Hospital	Chuncheon	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
KangWon National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subject's satisfaction based on the 10-point visual analog scale	The 10-point scale from 0 to 10	3 months
Secondary	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
Secondary	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
Secondary	Number of subjects who have a willingness to repeat the same regimen	using questionnaires: yes, no	3 months
Secondary	Rate of subjects with nausea	using questionnaires: yes, no	3 months
Secondary	Rate of subjects with vomiting	using questionnaires: yes, no	3 months
Secondary	Rate of subjects with abdominal pain	using questionnaires: yes, no	3 months
Secondary	Rate of subjects with abdominal distention	using questionnaires: yes, no	3 months
Secondary	Rate of subjects with thirst	using questionnaires: yes, no	3 months
Secondary	Rate of subjects with dizziness	using questionnaires: yes, no	3 months
Secondary	Rate of subjects with paresthesia	using questionnaires: yes, no	3 months
Secondary	Sodium level in mmol/L	change in electrolyte values before and after bowel preparation	an average of 1 year
Secondary	Potassium level in mmol/L	change in electrolyte values before and after bowel preparation	3 months
Secondary	Chloride level in mmol/L	change in electrolyte values before and after bowel preparation	3 months
Secondary	Magnesium level in mg/dL	change in electrolyte values before and after bowel preparation	3 months
Secondary	Phosphorus level in mg/dL	change in electrolyte values before and after bowel preparation	3 months
Secondary	Calcium level in mg/dL	change in electrolyte values before and after bowel preparation	3 months
Secondary	Blood urea nitrogen level in mg/dL	change in electrolyte values before and after bowel preparation	3 months
Secondary	Creatinine level in mg/dL	change in electrolyte values before and after bowel preparation	3 months
Secondary	Serum osmolarity in mmol/kg	change in osmolarity values before and after bowel preparation	3 months
Secondary	Urine osmolarity in mmol/L	change in osmolarity values before and after bowel preparation	3 months