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

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 .

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • 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
  • Drug: Sodium Picosulfate Solution(PicosolutionⓇ)
    • Sodium Picosulfate Solution(PicosolutionⓇ)

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • The rate of surgical site infection
    • Time Frame: 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 Measures

  • The quality of the bowel preparation
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Cancer Center, Korea
  • Collaborator
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sung Sil Park, Clinical Professor – National Cancer Center, Korea
  • Overall Official(s)
    • Hyoung-Chul Park, Doctor, Principal Investigator, National Cancer Center, Korea
  • Overall Contact(s)
    • Sung Sil Park, Doctor, +821092865451, 51873@ncc.re.kr

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