Infections

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Neoplasms

Digestive System Diseases

Communicable Diseases

Surgical Wound Infection

Surgical Wound

Wound Infection

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Postoperative Complications

Pharmaceutical Solutions

All Drugs and Chemicals

Gastrointestinal Agents

Picosulfate sodium

Laxatives

Cathartics

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

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Ⓡ)

Sung Sil Park, Doctor

Hyoung-Chul Park, Doctor

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 .

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.

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

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

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).

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

Using questionnaire, the tolerance will be scored after bowel preparation

Tolerability score Very comfortable: 5 Comfortable: 4 Fair: 3 Uncomfortable: 2 Very uncomfortable: 1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery	NCT04593446	Colorectal Canc...	Oral Sulfate Ta... Sodium Picosulf...	19 Years - 75 Years	National Cancer Center, Korea
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery	NCT04593446	Colorectal Canc...	Oral Sulfate Ta... Sodium Picosulf...	19 Years - 75 Years	National Cancer Center, Korea

Spots Global Cancer Trial Database for oral sulfate tablet(ora·fangⓡ)