Colorectal CancerPhase 2NCT04593446
Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery
A Phase 2 study testing Oral Sulfate Tablet(ORA·FANGⓇ) and Sodium Picosulfate Solution(PicosolutionⓇ) in people with Colorectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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 . Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oral Sulfate Tablet(ORA·FANGⓇ) and Sodium Picosulfate Solution(PicosolutionⓇ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer
- ASA score, 2 or less
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 10408
Sung Sil Park, Doctor, +821092865451, 51873@ncc.re.kr
Hyoung-Chul Park, Doctor, +821027771593, greatpa1@ncc.re.kr
About this study
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
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 .
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Oral Sulfate Tablet(ORA·FANGⓇ), Sodium Picosulfate Solution(PicosolutionⓇ)
- Keywords
- sodium picosulfate solution, oral sulfate tablet, surgical site infection
- Medical subject headings
- Colorectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Sodium Picosulfate Solution(PicosolutionⓇ)Drug
Sodium Picosulfate Solution(PicosolutionⓇ)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sodium Picosulfate Solution(PicosolutionⓇ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (2)
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
Measured: during surgery
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
Measured: 1 day after bowel preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, Daehang Hospital
- Responsible party
- Principal investigator, Sung Sil Park, National Cancer Center, Korea
- Investigators
- Hyoung-Chul Park, Doctor, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593446
- Sponsor's protocol ID
- NCC2020-0138
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04593446
- Acronym / sponsor ID
- NCC2020-0138
- Conditions
- Colorectal Cancer
- Keywords
- sodium picosulfate solution, oral sulfate tablet, surgical site infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, Daehang Hospital
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Sulfate Tablet(ORA·FANGⓇ) | Experimental | 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 |
| Sodium Picosulfate Solution(PicosolutionⓇ) | Active comparator | Drug: 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 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer
- ASA score, 2 or less
Key exclusion criteria (7 listed)
- Bowel obstruction
- FAP or IBD patients
- Emergency operation
- Pregnancy
- Breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Oral Sulfate Tablet(ORA·FANGⓇ) |
| Sodium Picosulfate Solution(PicosolutionⓇ)Sodium Picosulfate Solution(PicosolutionⓇ) | Drug | Sodium Picosulfate Solution(PicosolutionⓇ) |
Primary outcome
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).
2 secondary outcomes
The quality of the bowel preparation
Time frame: during surgery
The patient's tolerability for bowel preparation
Time frame: 1 day after bowel preparation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung-Chul Park, Doctor principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Sulfate Tablet(ORA·FANGⓇ) and Sodium Picosulfate Solution(PicosolutionⓇ) in people with Colorectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Sil Park, Doctor (+821092865451, 51873@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.