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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593446
• Other study ID #: NCC2020-0138
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: National Cancer Center, Korea
• Contact: Sung Sil Park, Doctor
• Phone: +821092865451
• Email: 51873[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Infection
• Surgical Wound Infection

Intervention

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
• Sodium Picosulfate Solution(Picosolution?)
Sodium Picosulfate Solution(Picosolution?)

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Daehang Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	30 days
Secondary	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	during surgery
Secondary	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	1 day after bowel preparation