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

National Cancer Center, Korea414 enrolled

Overview

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 .

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

414

Conditions

Colorectal Cancer

Interventions

Oral Sulfate Tablet(ORA·FANGⓇ)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Ⓡ)DRUG

Sodium Picosulfate Solution(PicosolutionⓇ)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 30 days

Secondary Outcomes

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

Time frame: 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

Time frame: 1 day after bowel preparation

Central Contacts

Sung Sil Park, Doctor

CONTACT

+821092865451 51873@ncc.re.kr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.