- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593446
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery : Phase II. Prospective, Randomised, Multicenter, Non-inferiority Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It has been reported that tablet oral sulphate solution(ORA·FANGⓇ) showed a successful bowel cleansing rate of 95.5%, which is similar to compared to sodium picosulfate solution(PicosolutionⓇ).
In terms of the rate of surgical site infection(SSI), sodium picosulfate solution(PicosolutionⓇ) showed 8% of SSI rate. However there is no report for the SSI rate of tablet oral sulphate solution(ORA·FANGⓇ). We aimed to compare the SSI rates between these two group.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sung Sil Park, Doctor
- Phone Number: +821092865451
- Email: 51873@ncc.re.kr
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
- Recruiting
- National Cancer Center, Korea
-
Contact:
- Sung Sil Park, Doctor
- Phone Number: +821092865451
- Email: 51873@ncc.re.kr
-
Contact:
- Hyoung-Chul Park, Doctor
- Phone Number: +821027771593
- Email: greatpa1@ncc.re.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer
- ASA score, 2 or less
Exclusion Criteria:
- Bowel obstruction
- FAP or IBD patients
- Emergency operation
- Pregnancy
- Breast feeding
- Severe medical condition such as severe cardiac,hepatic, or renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
- Allergy to drug and refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Sulfate Tablet(ORA·FANGⓇ)
Subjects who are randomized into experimental arm will receive 14 pills at 8 pm in the evening 2days before the surgery and another 14 pills on 6am in the morning 1day before the surgery
|
Subjects who are randomized into experimental arm will receive 14 pills at 8 pm in the evening 2days before the surgery and another 14 pills on 6am in the morning 1day before the surgery Subjects who are randomized into comparator will receive 170ml of solution with at 8 pm in the evening 2days before the surgery and another 170ml of solution on 6am in the morning 1day before the surgery |
Active Comparator: Sodium Picosulfate Solution(PicosolutionⓇ)
Subjects who are randomized into experimental arm will receive 170ml of solution with at 8 pm in the evening 2days before the surgery and another 170ml of solution on 6am in the morning 1day before the surgery
|
Sodium Picosulfate Solution(PicosolutionⓇ)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of surgical site infection
Time Frame: 30 days
|
The operator will evaluate the rate of the surgical site infection during the postoperative hospitalization period or the first outpatient visit after surgery.
We will use the definition of surgical site infection published in 1999 by the Centers for Disease Control and Prevention (CDC).
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The quality of the bowel preparation
Time Frame: during surgery
|
The operator will evaluate he quality of the bowel preparation using Arohchick bowel preparation scale during the surgery. Aronchick scale Excellent:5, good:4, fair:3, poor:2, inadequate:1 |
during surgery
|
The patient's tolerability for bowel preparation
Time Frame: 1 day after bowel preparation
|
Using questionnaire, the tolerance will be scored after bowel preparation Tolerability score Very comfortable: 5 Comfortable: 4 Fair: 3 Uncomfortable: 2 Very uncomfortable: 1 |
1 day after bowel preparation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hyoung-Chul Park, Doctor, National Cancer Center, Korea
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Postoperative Complications
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Wound Infection
- Infections
- Colorectal Neoplasms
- Surgical Wound Infection
- Gastrointestinal Agents
- Cathartics
- Picosulfate sodium
Other Study ID Numbers
- NCC2020-0138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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