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

Kangwon National University

Status and phase: Unknown; Phase 4

Conditions: Colonoscopy

Treatments: Drug: Oral sulfate solution (OSS); Drug: 2L PEG/Asc

Study type: Interventional

Funder types: Other

Identifiers

NCT03520361

2017-03-011

Details and patient eligibility

About

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).

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

Oral sulfate solution (OSS) taking group

Experimental group

Description:

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.

Treatment:

Drug: Oral sulfate solution (OSS)

2L PEG/Asc taking group

Active Comparator group

Description:

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.

Treatment:

Drug: 2L PEG/Asc