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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-31

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 .

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Oral Sulfate Tablet(ORA·FANGⓇ)

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Sodium Picosulfate Solution(PicosolutionⓇ)

Intervention Type DRUG

Sodium Picosulfate Solution(PicosolutionⓇ)

Interventions

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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

Intervention Type DRUG

Sodium Picosulfate Solution(PicosolutionⓇ)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer
2. ASA score, 2 or less

Exclusion Criteria

1. Bowel obstruction
2. FAP or IBD patients
3. Emergency operation
4. Pregnancy
5. Breast feeding
6. Severe medical condition such as severe cardiac,hepatic, or renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
7. Allergy to drug and refusal to participate in the study

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes