Bowel Preparation QualityPhase 3NCT02540031
The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy
A Phase 3 study testing Additional oral preparation (3L of PEG+Asc, "Coolprep®") and Standard oral preparation (2L of PEG+Asc, "Coolprep®") in people with Bowel Preparation Quality, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation Quality
- What is being tested?
- Additional oral preparation (3L of PEG+Asc, "Coolprep®") and Standard oral preparation (2L of PEG+Asc, "Coolprep®")
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Jun 2018
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy
Who cannot join
- known hypersensitivity to polyethylene glycol
- severe congestive heart failure [New York Heart Association (NYHA) grade III or grade IV]
- severe renal insufficiency (creatinine clearance <30 ml/min)
- hemodynamic instability
- suspected intestinal obstruction or perforation
- compromised swallowing reflex or altered mental status
- pregnancy or lactating woman
- patients who declined to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Medical Center
Daegu, 700-712
About this study
Official title: The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy in Patients Showing Brown Effluents
Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.
- Conditions
- Bowel Preparation Quality
- Being tested
- Additional oral preparation (3L of PEG+Asc, "Coolprep®"), Standard oral preparation (2L of PEG+Asc, "Coolprep®")
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional oral preparation (3L of PEG+Asc, "Coolprep®")Drug
Also called Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L
The interventional or experimental arm will receive 1l of additional PEG+Asc, "Coolprep®" on the day of colonoscopy
- Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Standard oral preparation (2L of PEG+Asc, "Coolprep®")Drug
Also called Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L
The control arm will receive currently used oral preparation (2l of PEG+Asc, "Coolprep®") for colonoscopy
- Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
| Study group | Role | What they receive |
|---|---|---|
| Additional oral preparation | Experimental | The investigational or experimental arm will receive standard oral preparation plus additional oral preparation (1l of polyethylene glycol (PEG)+ascorbic acid (Asc)) for colonoscopy.
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g Receives: Drug: Additional oral preparation (3L of PEG+Asc, "Coolprep®") |
| Standard oral preparation | Active comparator | The control arm will receive currently used oral preparation (2L of polyethylene glycol+ascorbic acid) for colonoscopy.
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g Receives: Drug: Standard oral preparation (2L of PEG+Asc, "Coolprep®") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale
Measured: Day 1
Secondary outcomes (3)
Adenoma detection rate
Number of adenomatous polyps
Measured: Day 1
Patient compliance
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
Measured: Baseline
Patient satisfaction
Patient's perception of the preparation method as self-reported on a pre-procedure questionnaire.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation QualityStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
- Investigators
- Eun Soo Kim, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540031
- Sponsor's protocol ID
- 2015-06-014-003
- Status last verified
- Jul 2018
- First submitted
- 8 Aug 2015
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fatima H, Johnson CS, Rex DK. Patients' description of rectal effluent and quality of bowel preparation at colonoscopy. Gastrointest Endosc. 2010 Jun;71(7):1244-1252.e2. doi: 10.1016/j.gie.2009.11.053. Epub 2010 Apr 1.
PubMed 20362286
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy in Patients Showing Brown Effluents
- ClinicalTrials.gov ID
- NCT02540031
- Acronym / sponsor ID
- 2015-06-014-003
- Conditions
- Bowel Preparation Quality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 3 Sep 2015 (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.
Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional oral preparation | Experimental | Drug: Additional oral preparation (3L of PEG+Asc, "Coolprep®")The investigational or experimental arm will receive standard oral preparation plus additional oral preparation (1l of polyethylene glycol (PEG)+ascorbic acid (Asc)) for colonoscopy. * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g |
| Standard oral preparation | Active comparator | Drug: Standard oral preparation (2L of PEG+Asc, "Coolprep®")The control arm will receive currently used oral preparation (2L of polyethylene glycol+ascorbic acid) for colonoscopy. * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy
Key exclusion criteria (8 listed)
- known hypersensitivity to polyethylene glycol
- severe congestive heart failure [New York Heart Association (NYHA) grade III or grade IV]
- severe renal insufficiency (creatinine clearance <30 ml/min)
- hemodynamic instability
- suspected intestinal obstruction or perforation
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 |
|---|---|---|
| Additional oral preparation (3L of PEG+Asc, "Coolprep®")Also: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3LThe interventional or experimental arm will receive 1l of additional PEG+Asc, "Coolprep®" on the day of colonoscopy * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g | Drug | Additional oral preparation |
| Standard oral preparation (2L of PEG+Asc, "Coolprep®")Also: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2LThe control arm will receive currently used oral preparation (2l of PEG+Asc, "Coolprep®") for colonoscopy * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g | Drug | Standard oral preparation |
Primary outcome
Quality of bowel preparation
Time frame: Day 1
The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale
3 secondary outcomes
Adenoma detection rate
Time frame: Day 1
Patient compliance
Time frame: Baseline
Patient satisfaction
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Results publication: PubMed 20362286Fatima H, Johnson CS, Rex DK. Patients' description of rectal effluent and quality of bowel preparation at colonoscopy. Gastrointest Endosc. 2010 Jun;71(7):1244-1252.e2. doi: 10.1016/j.gie.2009.11.053. Epub 2010 Apr 1.
Related trials for Bowel Preparation Quality
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A Multi-Center Randomized Controlled Trial on the Impact of Disease Subtype-Based Active Video Education on Bowel Preparation Quality in Patients With Inflammatory Bowel Disease
Inflammatory Bowel Diseases
Not yet recruitingObservational study
Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate
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The Efficacy of AI-Driven Feces Identification for Bowel Preparation Prior to Colonoscopy
AI App Improves Bowel Preparation Quality for Colonoscopy
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.
Eun Soo Kim principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Additional oral preparation (3L of PEG+Asc, "Coolprep®") and Standard oral preparation (2L of PEG+Asc, "Coolprep®") in people with Bowel Preparation Quality, run by Kyungpook National University Hospital 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 1 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: finished, as of the sponsor's last update on 20 Jul 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of bowel preparation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540031, which also lists 1 linked publication.
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 Jul 2018.