Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery

Study Overview
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Brief Summary
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This is a prospective randomized study to evaluate the difference in the rate of surgical site infection between the patients who used Sodium Picosulfate solution(PicosolutionⓇ) and tablet Oral Sulphate Solution(ORA·FANGⓇ) for bowel preparation before colorectal cancer surgery .

Detailed Description
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Oral Sulfate Tablet(ORA·FANGⓇ)
* Drug: Sodium Picosulfate Solution(PicosolutionⓇ)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Sulfate Tablet(ORA·FANGⓇ)<br>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 | Drug: Oral Sulfate Tablet(ORA·FANGⓇ)<br>* 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<br>|
| Active Comparator: Sodium Picosulfate Solution(PicosolutionⓇ)<br>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 | Drug: Sodium Picosulfate Solution(PicosolutionⓇ)<br>* Sodium Picosulfate Solution(PicosolutionⓇ)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of surgical site infection | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium picosulfate solution, oral sulfate tablet, surgical site infection