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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Oral Sulfate Tablet(ORA·FANGⓇ); Drug: Sodium Picosulfate Solution(PicosolutionⓇ)

Study type: Interventional

Funder types: Other

Identifiers

NCT04593446

NCC2020-0138

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 414 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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414 participants in 2 patient groups

Oral Sulfate Tablet(ORA·FANGⓇ)

Experimental group

Description:

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

Treatment:

Drug: Oral Sulfate Tablet(ORA·FANGⓇ)

Sodium Picosulfate Solution(PicosolutionⓇ)

Active Comparator group

Description:

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

Treatment:

Drug: Sodium Picosulfate Solution(PicosolutionⓇ)