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Surgical site infection after bowel preparation for colorectal cancer with Sodium picosulfate and Magnesium citrate versus Clicool powder : A Randomized Non-inferiority Trial

Status Approved

First Submitted Date

2019/01/15
Registered Date

2019/03/25
Last Updated Date

2019/10/10

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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	KCT0003662
Unique Protocol ID	KNUCH2018-05-018-004
Public/Brief Title	A study on the surgical site infection according to the type of bowel cleansing used in patients before colorectal cancer surgery
Scientific Title	Surgical site infection after bowel preparation for colorectal cancer with Sodium picosulfate and Magnesium citrate versus Clicool powder : A Randomized Non-inferiority 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	KNUCH2018-05-018-004
Approval Date	2018-12-17
Institutional Review Board Name	KYUNGPOOK NATIONAL UNIVERSITY CHILGOK HOSPITAL Institutional Review Board
Institutional Review Board Address	807, Hoguk-ro, Buk-gu, Daegu
Institutional Review Board Telephone	053-200-2162
Data Monitoring Committee	No

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	Jun Seok Park
Title	Professor
Telephone	+82-53-200-2772
Affiliation	Kyungpook National University Hospital
Address	Kyungpook National University Medical Center
Contact Person for Public Queries
Name	Jun Seok Park
Title	Professor
Telephone	+82-53-200-2772
Affiliation	Kyungpook National University Hospital
Address	Kyungpook National University Medical Center
Contact Person for Updating Information
Name	Seung Ho Song
Title	Clinical fellow
Telephone	+82-53-200-2772
Affiliation	Kyungpook National University Medical Center
Address	Kyungpook National University Medical Center

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	Multi-center Number of center : 4
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-07-03 Actual
Target Number of Participant	298
Primary Completion Date	2020-10-01 , Anticipated
Study Completion Date	2020-11-01 , Anticipated
Name of Study	Kyungpook National University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2019-07-03 ,
Recruitment Status by Participating Study Site 2
Name of Study	Keimyung University Dongsan Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-11-01 ,
Recruitment Status by Participating Study Site 3
Name of Study	Daegu Catholic University Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-11-01 ,
Recruitment Status by Participating Study Site 4
Name of Study	Yeongnam University Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-11-01 ,

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	Pharmbio Korea
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyungpook National University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The use of polyethylene glycol before colorectal cancer surgery is well known to reduce postoperative wound infection and anastomotic leakage compared to simple enema. But, a large amount of water (4L), and the patients are required to take the medicine separately, which causes a lot of discomfort to the patients. Recently, Pocisolution(Sodium picosulfate and Magnesium citrate), approved by the US Food and Drug Administration, has similar effect in bowel cleansing before colonoscopy even with a small amount (150ml) of water. However, this is not a comparison of preoperative patients, but a comparison of patients before colonoscopy. The purpose of this study was to evaluate the prevalence of surgical site infection and postoperative satisfaction of patients and surgeons when using these bowel cleansers. And determine whether Picosolution have non-inferiority compared to polyehylene glycol and whether it can be replaced with an bowel cleanser before surgery.

Study Summary Information

Lay Summary

The use of polyethylene glycol before colorectal cancer surgery is well known to reduce postoperative wound infection and anastomotic leakage compared to simple enema. But, a large amount of water (4L), and the patients are required to take the medicine separately, which causes a lot of discomfort to the patients. Recently, Pocisolution(Sodium picosulfate and Magnesium citrate), approved by the US Food and Drug Administration, has similar effect in bowel cleansing before colonoscopy even with a small amount (150ml) of water. However, this is not a comparison of preoperative patients, but a comparison of patients before colonoscopy. The purpose of this study was to evaluate the prevalence of surgical site infection and postoperative satisfaction of patients and surgeons when using these bowel cleansers. And determine whether Picosolution have non-inferiority compared to polyehylene glycol and whether it can be replaced with an bowel cleanser before surgery.

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	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	After the written consent to participate in the study on the day before surgery, we randomly divided into two groups using computer. In control group, take Picosolution 170mL and 500mL of water at 3 pm on the day before surgery. After 3 hours, tace Picosolution 170mL and 500mL of water. In study group, take Clicool powder and 1L of water at 3 pm on the day before surgery. After 2 hours, take Clicool powder and 1 L of water. Then drink 1L of water for 1 hour. Both groups will complete a simple survey at 10 pm.
Number of Arms	2
Arm 1	Arm Label Picosolution: Sodium picosulfate and Magnesium citrate
	Target Number of Participant 149
	Arm Type Experimental
	Arm Description Take Picosolution 170mL and 500mL of water at 3 pm on the day before surgery. After 3 hours, tace Picosolution 170mL and 500mL of water. Write a simple survey at 10 pm.
Arm 2	Arm Label Clicool powder: Polyethylene glycol, NaCl, KCl, Ascorbic acid, Sodium ascorbate, Sodium sulfate anhydrous
	Target Number of Participant 149
	Arm Type Active comparator
	Arm Description Take Clicool powder and 1L of water at 3 pm on the day before surgery. After 2 hours, take Clicool powder and 1 L of water. Then drink 1L of water for 1 hour. Write a simple survey at 10 pm.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C18.9)Malignant neoplasm of colon, unspecified Colorectal Neoplasms
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~75Year
	Description 1. Patients who were diagnosed with colorectal cancer and were asked to undergo surgery 2. Patients requiring bowel cleansing 3. American Society of Anesthesiologists (ASA) Score 1 or 2
Exclusion Criteria	1. Bowel obstruction 2. Patients requiring colonoscopy before surgery 3. Patients who received preoperative radiotherapy 4. Mental illness 5. Emergency operation 6. Patients who received bowel cleansing by adding antibiotics
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	/Safety/Efficacy
Outcome	Surgical site infection
Timepoint	3 days after surgery, Day of discharge
Secondary Outcome(s) 1
Outcome	ABPS (Aronchick Bowel Preparation Scale), OBPS (Ottawa Bowel Preparation Scale)
Timepoint	Immediately after surgery
Secondary Outcome(s) 2
Outcome	Compliance of bowel cleaner
Timepoint	After the last bowel cleaner

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	No

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