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

NCT04593446 | Unknown Phase 2

• 1 other identifier: NCC2020-0138
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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 .

Conditions

Colorectal Cancer

Keywords

sodium picosulfate solution; oral sulfate tablet; surgical site infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The quality of the bowel preparation

  during surgery

• The patient's tolerability for bowel preparation

  1 day after bowel preparation

Study Arms (2)

Oral Sulfate Tablet(ORA·FANGⓇ)

EXPERIMENTAL

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

Drug: Oral Sulfate Tablet(ORA·FANGⓇ)

Sodium Picosulfate Solution(PicosolutionⓇ)

ACTIVE COMPARATOR

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

Drug: Sodium Picosulfate Solution(PicosolutionⓇ)

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

Oral Sulfate Tablet(ORA·FANGⓇ)

Sodium Picosulfate Solution(PicosolutionⓇ) DRUG

Sodium Picosulfate Solution(PicosolutionⓇ)

Sodium Picosulfate Solution(PicosolutionⓇ)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer
• ASA score, 2 or less

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Daehang Hospital: collaborator

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyoung-Chul Park, Doctor

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Sil Park, Doctor

CONTACT

+821092865451; 51873@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 20, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)