Stasis; ColonNCT01774175
Comparison Between Coolprep and Picolyte for Bowel Cleansing
An observational study of Stasis; Colon, run by Gachon University Gil Medical Center.
Trial summary
The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stasis; Colon
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2014
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include a total of 250 patients. All patient randomized PEG+ascorbica acid(coolprep) and picosulfate magnesium citrate(picolyte), each group will include 125 patients. The investigators decided sample size to 200 patients after comparing Ottawa scale. The investigators assumed there would be defference about 20 percent of bowel preparation between them. Recently, Ottawa scale of bowel preparation reported about 5 points. The investigators assumed that there could be differences between them about 1 point. The investigators decided each groups per 100 patients, if significance level was 0.05 and test power is 80 percent. The investigators start this study with a total of 220 patients because 10 percent of 200 patients could be drop out. The investigators readjust about 30 patients after interim analysis.
Who may be able to join
- Age : over 19 years
- Who will be done colonoscopy
- Who accepted informed consent
Who cannot join
- Age : over 80 years
- Electrolyte imbalance
- Liver function test abnormality, ascites(over 2 times, >Child class B)
- ARF or CRF(GFS<30)
- Recent MI(< 6months) or Unstable angina pectoris
- Congestive heart failure(NYHA > 2)
- Inflammatory bowel disease
- Abdominal minor surgery
About this study
Official title: A Randomised Controlled Trial of a 2 Litre Polyethylene Glycol Solution + Ascorbic Acid Versus Sodium Picosulphate + Magnesium Citrate Solution for Bowel Cleansing Prior to Colonoscopy
The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.
Read the detailed description
The investigators can find easily colon cancer and poly by colonoscopy, but bowel preparation is very important to find the lesion. Desirable bowel preparation drug must be clearly removed stool, effective on colonoscopic finding and pathologic finding, quickly administrated agent and eliminated stool, comfort for patient, and less side effects.
PEG is very safe osmotic laxative. New agent(coolprep) which add ascorbic acid is less salty and less volume. Picosulfate+magnesium citrate(picolyte) taste orange, can be easily prepared bowel for colonoscopy by good taste and small volume. Magnesium with citrate acts like osmotic agent, picosulfate acts irritant agent.
The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.
- Conditions
- Stasis; Colon
- Keywords
- Bowel preparation, PEG with ascorbic acid, Picosulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coolprep | A total of 2L A : NaCl 5.382g KCl 2.03g Sodium sulfate 15g Polyethylene glycol 3350 200.0g B : Ascorbic acid 9.4g Sodium ascorbate 11.8g | |
| Picolyte | Sodium picosulfate 30.0mg Magnesium citrate 10.5g + 36.0g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottawa scale
- Ottawa scale
Individual evaluation of right, mid, and left colon:
No liquid - 0 Minimal liquid, no suctioning required - 1 Suction required to see mucosa - 2 Wash and suction - 3 Solid stool,not washable - 4
Evaluation of the entire colon:
Overall quantity of fluid 0-2 minimal -0 moderate - 1 Large - 2
- Aronchick score scale Minimal liquid, visible more than 95% of colon mucosa - excellent Clear liquid covered 5~25% of mucosa, visible more than 90% of colon mucosa - good Solid stool, washable, visible more than 90% of colon mucosa - Fair Solid stool, not washable, visible less than 90% of colon mucosa not washable - Poor Bowel preparation is needed - Inadequate
Measured: Ottawa scale will be checked at the end of the colonoscopy. Participants won't be followed up because of this study.
Secondary outcomes (2)
Patient satisfaction
Taste, Comfort
Measured: Questionnaires related with satisfaction and side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.
Symptoms related with bowel preparation
Nausea, Vomiting, Abdominal discomfort, Abdominal distension, Headache, Dizziness, Numbness
Measured: Questionnaires related with side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stasis; ColonStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Jun Won, Gachon University Gil Medical Center
- Investigators
- Jun Won Chung, Professor, Study director, Gachon University Gil Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774175
- Sponsor's protocol ID
- COOLPREPICOLYTE
- Status last verified
- Jan 2013
- First submitted
- 17 Jan 2013
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a 2 Litre Polyethylene Glycol Solution + Ascorbic Acid Versus Sodium Picosulphate + Magnesium Citrate Solution for Bowel Cleansing Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT01774175
- Acronym / sponsor ID
- COOLPREPICOLYTE
- Conditions
- Stasis; Colon
- Keywords
- Bowel preparation, PEG with ascorbic acid, Picosulfate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 23 Jan 2013 (estimated)
- 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.
The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.
Detailed description
The investigators can find easily colon cancer and poly by colonoscopy, but bowel preparation is very important to find the lesion. Desirable bowel preparation drug must be clearly removed stool, effective on colonoscopic finding and pathologic finding, quickly administrated agent and eliminated stool, comfort for patient, and less side effects.
PEG is very safe osmotic laxative. New agent(coolprep) which add ascorbic acid is less salty and less volume. Picosulfate+magnesium citrate(picolyte) taste orange, can be easily prepared bowel for colonoscopy by good taste and small volume. Magnesium with citrate acts like osmotic agent, picosulfate acts irritant agent.
The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coolprep | – | –A total of 2L A : NaCl 5.382g KCl 2.03g Sodium sulfate 15g Polyethylene glycol 3350 200.0g B : Ascorbic acid 9.4g Sodium ascorbate 11.8g |
| Picolyte | – | –Sodium picosulfate 30.0mg Magnesium citrate 10.5g + 36.0g |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include a total of 250 patients. All patient randomized PEG+ascorbica acid(coolprep) and picosulfate magnesium citrate(picolyte), each group will include 125 patients. The investigators decided sample size to 200 patients after comparing Ottawa scale. The investigators assumed there would be defference about 20 percent of bowel preparation between them. Recently, Ottawa scale of bowel preparation reported about 5 points. The investigators assumed that there could be differences between them about 1 point. The investigators decided each groups per 100 patients, if significance level was 0.05 and test power is 80 percent. The investigators start this study with a total of 220 patients because 10 percent of 200 patients could be drop out. The investigators readjust about 30 patients after interim analysis.
Key inclusion criteria (3 listed)
- Age : over 19 years
- Who will be done colonoscopy
- Who accepted informed consent
Key exclusion criteria (8 listed)
- Age : over 80 years
- Electrolyte imbalance
- Liver function test abnormality, ascites(over 2 times, >Child class B)
- ARF or CRF(GFS<30)
- Recent MI(< 6months) or Unstable angina pectoris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ottawa scale
Time frame: Ottawa scale will be checked at the end of the colonoscopy. Participants won't be followed up because of this study.
* Ottawa scale Individual evaluation of right, mid, and left colon: No liquid - 0 Minimal liquid, no suctioning required - 1 Suction required to see mucosa - 2 Wash and suction - 3 Solid stool,not washable - 4 Evaluation of the entire colon: Overall quantity of fluid 0-2 minimal -0 moderate - 1 Large - 2 * Aronchick score scale Minimal liquid, visible more than 95% of colon mucosa - excellent Clear liquid covered 5~25% of mucosa, visible more than 90% of colon mucosa - good Solid stool, washable, visible more than 90% of colon mucosa - Fair Solid stool, not washable, visible less than 90% of colon mucosa not washable - Poor Bowel preparation is needed - Inadequate
2 secondary outcomes
Patient satisfaction
Time frame: Questionnaires related with satisfaction and side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.
Symptoms related with bowel preparation
Time frame: Questionnaires related with side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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.
Jun Won Chung, Professor study director
Gachon University Gil Medical School
Questions about this trial
What is this clinical trial studying?
An observational study of Stasis; Colon, run by Gachon University Gil Medical Center.
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 3 inclusion and 8 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 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ottawa scale (time frame: Ottawa scale will be checked at the end of the colonoscopy. Participants won't be followed up because of this study.). 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 25 Jan 2013.