Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose

NCT03315949 | Completed Phase 3 Results DMC

• 1 other identifier: OC17MESI0060
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy, same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing for morning colonoscopy was validated. To date, there was no study which compared the bowel cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The aim of current study is to compare the bowel cleansing efficacy, adverse events, and patient's tolerability between the two group. Subjects who underwent colonoscopy for various reasons were included. After agreeing to participate in the study, study participants were randomly assigned to split dose or same day dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15 minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose group, bowel cleansing was started from 5AM for subjects who were scheduled to receive colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested 2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy. Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and laboratory tests were checked before colonoscopy. Study participants completed questionnaire which contained patient's satisfaction, tolerability, and adverse event during bowel cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared between the two groups. Successful bowel cleansing was estimated 85% for split dose group. The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352 subjects will be recruited.

Conditions

Unrecognized Condition

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale

  Primary endpoint=Successful bowel cleansing (all segmental score 2 or above) \* Boston bowel preparation scale (0-9) Sum of 3 segment of bowel. 0=inadequate 1. poor 2. good 3. excellent

  Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal

Study Arms (2)

Same-day dose group

EXPERIMENTAL

Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.

Drug: Polyethylene Glycol (PEG)

Split-dose group

ACTIVE COMPARATOR

Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.

Drug: Polyethylene Glycol (PEG)

Interventions

Polyethylene Glycol (PEG) DRUG

Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy

Also known as: colyte

Same-day dose group; Split-dose group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all subjects who undergo colonoscopy for various reasons.

You may not qualify if:

• hemodynamic instability
• ileus or bowel obstruction
• active inflammatory bowel disease
• advanced colon cancer

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, 02143, South Korea

Location

MeSH Terms

Interventions

Polyethylene Glycols; Golytely

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Tae-Geun Gweon
• Organization: College of Medicine, The Catholic University of Korea

gweontae@naver.com

82 32 340 2228

Study Officials

• Tae-Geun Gweon, Ph.D

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: May 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: August 13, 2020
• Results First Posted: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)