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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oral Sulfate Tablet(ORA·FANGⓇ)
Sodium Picosulfate Solution(PicosolutionⓇ)
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring sodium picosulfate solution, oral sulfate tablet, surgical site infection

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • National Cancer Center, KoreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral Sulfate Tablet(ORA·FANGⓇ)

Sodium Picosulfate Solution(PicosolutionⓇ)

Arm 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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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

Full Information

First Posted
October 12, 2020
Last Updated
October 19, 2020
Sponsor
National Cancer Center, Korea
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital, Daehang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04593446
Brief Title
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital, Daehang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
sodium picosulfate solution, oral sulfate tablet, surgical site infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Sulfate Tablet(ORA·FANGⓇ)
Arm Type
Experimental
Arm 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
Arm Title
Sodium Picosulfate Solution(PicosolutionⓇ)
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Oral Sulfate Tablet(ORA·FANGⓇ)
Intervention 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 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
Intervention Type
Drug
Intervention Name(s)
Sodium Picosulfate Solution(PicosolutionⓇ)
Intervention Description
Sodium Picosulfate Solution(PicosolutionⓇ)
Primary Outcome Measure Information:
Title
The rate of surgical site infection
Description
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 Outcome Measure Information:
Title
The quality of the bowel preparation
Description
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
Title
The patient's tolerability for bowel preparation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer ASA score, 2 or less Exclusion Criteria: Bowel obstruction FAP or IBD patients Emergency operation Pregnancy Breast feeding Severe medical condition such as severe cardiac,hepatic, or renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)), Allergy to drug and refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Sil Park, Doctor
Phone
+821092865451
Email
51873@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung-Chul Park, Doctor
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Sil Park, Doctor
Phone
+821092865451
Email
51873@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Hyoung-Chul Park, Doctor
Phone
+821027771593
Email
greatpa1@ncc.re.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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