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

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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