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Comparison of bowel cleansing efficacy of two bowel preparation methods for afternoon colonoscopy in patients with gastrectomy : A single center, operator blinded, prospective randomized controlled trial

Status Approved

First Submitted Date

2018/01/17
Registered Date

2018/02/21
Last Updated Date

2018/09/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002699
Unique Protocol ID	OC17MESI0031
Public/Brief Title	Comparison of bowel cleansing efficacy of two bowel preparation methods for afternoon colonoscopy in patients with gastrectomy : A single center, operator blinded, prospective randomized controlled trial
Scientific Title	Comparison of bowel cleansing efficacy of two bowel preparation methods for afternoon colonoscopy in patients with gastrectomy : A single center, operator blinded, prospective randomized controlled trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	OC17MESI0031
Approval Date	2017-03-27
Institutional Review Board Name	Instituitional Review Board of Incheon St. Mary's Hospital
Institutional Review Board Address	56, Dongsu-ro, Bupyeong-gu, Incheon
Institutional Review Board Telephone	032-280-5371
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Tae-Geun Gweon
Title	Professor
Telephone	+82-32-280-5051
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address	56, Dongsu-ro, Bupyeong-gu, Incheon, 21431, Republic of Korea
Contact Person for Public Queries
Name	Tae-Geun Gweon
Title	Professor
Telephone	+82-32-280-5051
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address	56, Dongsu-ro, Bupyeong-gu, Incheon, 21431, Republic of Korea
Contact Person for Updating Information
Name	Tae-Geun Gweon
Title	Professor
Telephone	+82-32-280-5051
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address	56, Dongsu-ro, Bupyeong-gu, Incheon, 21431, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2017-04-17 Actual
Target Number of Participant	206
Primary Completion Date
Study Completion Date
Name of Study	The Catholic University of Korea, Incheon St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2017-04-17 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	The Catholic University of Korea, Incheon St. Mary's Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Incheon St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Proper bowel cleansing is essential for the precise detection of colorectal neoplasia. Poor bowel preparation is for low adenoma detection rate (ADR). Reexamination is recommended in patients with poor bowel preparation, which causes patients’ inconvenience and increase of medical cost. Therefore, proper bowel cleansing > 85% is quality indicator for colonoscopy. Patients with gastric cancer is high risk for colorectal cancer and adenoma. Therefore qualified colonoscopy is essential for patients with gastrectomy. For proper bowel cleansing and favorable ADR, bowel preparation is recommended as slit dose. Split dose is regimen is recommend for bowel cleansing method to obtain better bowel cleansing efficacy in various guidelines. For afternoon colonoscopy, same-day dose is recommended as alternative of split dose regimen. Patients with gastrectomy are high risk for poor bowel preparation because of bowel adhesion. Furthermore decreased gastric volume after surgery is associated with patients' inconvenience to ingest large volume. To date, there was no study which compared the bowel cleansing efficacy between split dose and same-day dose for afternoon colonoscopy in patients with gastrectomy. The aims of current study is to compare the bowel cleansing efficacy and patients' tolerability for patients with gastrectomy who undergo afternoon colonoscopy.

Study Summary Information

Lay Summary

Proper bowel cleansing is essential for the precise detection of colorectal neoplasia. Poor bowel preparation is for low adenoma detection rate (ADR). Reexamination is recommended in patients with poor bowel preparation, which causes patients’ inconvenience and increase of medical cost. Therefore, proper bowel cleansing &gt; 85&#37; is quality indicator for colonoscopy. 
Patients with gastric cancer is high risk for colorectal cancer and adenoma. Therefore qualified colonoscopy is essential for patients with gastrectomy. For proper bowel cleansing and favorable ADR, bowel preparation is recommended as slit dose. Split dose is regimen is recommend for bowel cleansing method to obtain better bowel cleansing efficacy in various guidelines.
For afternoon colonoscopy, same-day dose is recommended as alternative of split dose regimen. Patients with gastrectomy are high risk for poor bowel preparation because of bowel adhesion. Furthermore decreased gastric volume after surgery is associated with patients&#39; inconvenience to ingest large volume. To date, there was no study which compared the bowel cleansing efficacy between split dose and same-day dose for afternoon colonoscopy in patients with gastrectomy. The aims of current study is to compare the bowel cleansing efficacy and patients&#39; tolerability for patients with gastrectomy who undergo afternoon colonoscopy.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Screening
Phase	Phase3
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	Bowel cleansing with PEG 4 L for afternoon colonoscopy. Split dose group ingest PEG 2L 1 day before colonoscopy. Same-day dose group ingest PEG 4L on the day of colonoscopy
Number of Arms	2
Arm 1	Arm Label split dose group
	Target Number of Participant 103
	Arm Type Experimental
	Arm Description PEG 2L is ingested 1 day before colonoscopy. Remaining 2L is ingested on the day of colonoscoyp
Arm 2	Arm Label Same-day dose group
	Target Number of Participant 103
	Arm Type Experimental
	Arm Description PEG 4L is ingested on the day of colonoscopy

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C16.99)Malignant neoplasm of stomach, unspecified, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description Patients with gastrectomy for gastric cancer and undergo colonoscopy in the afternoon
Exclusion Criteria	bowel resection hysterectomy C-sec patients with chemotherapy bowel movement < 3 /week
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Bsoton bowel preparation scale
Timepoint	withdrawal of colonoscopy
Secondary Outcome(s) 1
Outcome	laboratory test, adverse events
Timepoint	after ingestion of bowel cleanser

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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