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

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Recruiting

CT.gov ID

NCT04593446

Collaborator

Seoul National University Hospital (Other), Seoul National University Bundang Hospital (Other), Daehang Hospital (Other)

414

Enrollment

Location

Arms

Anticipated Duration (Months)

29.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Oral Sulfate Tablet(ORA·FANGⓇ) Drug: Sodium Picosulfate Solution(PicosolutionⓇ)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

414 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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	Drug: 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 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	Drug: Sodium Picosulfate Solution(PicosolutionⓇ) Sodium Picosulfate Solution(PicosolutionⓇ)

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

Drug: 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 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

Drug: Sodium Picosulfate Solution(PicosolutionⓇ)

Sodium Picosulfate Solution(PicosolutionⓇ)

Outcome Measures

Primary Outcome Measures

The rate of surgical site infection [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).

Secondary Outcome Measures

The quality of the bowel preparation [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
The patient's tolerability for bowel preparation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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