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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: Sodium Picosulfate Solution(PicosolutionⓇ); Drug: Oral Sulfate Tablet(ORA·FANGⓇ)

• Registration Number: NCT04593446
• Lead Sponsor: National Cancer Center, Korea

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 .

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 Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-19
• Last Update Submitted: 2020-10-19
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20
• Study Start: 2020-11-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Picosulfate Solution(PicosolutionⓇ)	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
Oral Sulfate Tablet(ORA·FANGⓇ)	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Center, Korea; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of