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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

NCT04593446 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2020-10-20

No results posted yet for this study

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

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Ⓡ)

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Daehang Hospital

    collaborator OTHER

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Hyoung-Chul Park, Doctor · National Cancer Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04593446 on ClinicalTrials.gov