Bowel PreparationNCT03248726
Comparing Single-dose Low-volume PEG Plus Bisacodyl vs. Split-dose PEG for Bowel Preparation in Morning Colonoscopy
A study testing Polyethylene glycol and bisacodyl and Split-dose polyethylene glycol in people with Bowel Preparation, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation which makes bowel preparation an important issue. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Polyethylene glycol and bisacodyl and Split-dose polyethylene glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2017to 30 Sep 2019
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-70 years.
- Out-patient department ambulatory patient.
- Patients who have indications to receive colonoscopy.
Who cannot join
- Age is under 20 or over 70
- Have severe renal impairment (hemodialysis or eGFR<30).
- Have severe congestive heart failure (NYHAⅢorⅣ).
- Pregnant or lactating, or women is under oral contraceptive.
- Have history of bowel obstruction or resection, known or suspected gastroparesis acute gastric/intestinal ulcer, toxic colitis or megacolon
- Be allergic to polyethylene glycol (PEG) or bisacodyl.
Show all 9Show fewer
- Have severe constipation ( ≤ 1 bowel movement per week).
- Patient who has Phenylketonuria.
- Refuse to sign consent to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Single-dose (Morning) Low-volume Polyethylene Glycol Plus Bisacodyl Versus Split-dose Polyethylene Glycol for Bowel Preparation Efficacy in Patient Receiving Morning Colonoscopy
Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation which makes bowel preparation an important issue. Hence, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.
Read the detailed description
Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation. That makes bowel preparation an important issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and safety. However, there are many different adjunctive, dose, timing of administration in PEG preparation. Some may decrease patient tolerability due to large fluid volume, and some may influence patient's life and sleep quality when performing bowel preparation. Here, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.
- Conditions
- Bowel Preparation
- Being tested
- Polyethylene glycol and bisacodyl, Split-dose polyethylene glycol
- Keywords
- Polyethylene Glycol, Bisacodyl, Colonoscopy, Bowel preparation, Ottawa bowel preparation scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol and bisacodylDrug
Also called Dulcolax®, Klean-prep®
Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination.
Split-dose polyethylene glycolDrug
Also called Klean-prep®
Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day.
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol and bisacodyl | Experimental | In order to decrease the dose and frequency of polyethylene glycol, we added bisacodyl at the night before examination to facilitate the action of polyethylene glycol given solely in the morning of examination. Receives: Drug: Polyethylene glycol and bisacodyl |
| Split-dose polyethylene glycol | Active comparator | The standard regimen of polyethylene glycol was used in this group. The participant of this arm receives polyethylene glycol in the evening before examination and the morning of examination . Receives: Drug: Split-dose polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ottawa Bowel Preparation Scale
Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as "good preparation".
Measured: Within 24 hours after colonoscopy
Secondary outcomes (1)
Life disturbance
Evaluate patients life disturbance with a questionnaire before performing a colonoscopy. The questionnaire including side effect, sleep quality, interference of life/work, and tendency of same bowel preparation method at next colonoscopy.
Measured: 30 minutes before patient receive colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start14 Jul 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Cheng Huang, Bachelor, Principal investigator, Gastroenterology division, Internal Medicine Department, Wanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248726
- Sponsor's protocol ID
- N201610042
- Status last verified
- Oct 2019
- First submitted
- 31 May 2017
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single-dose (Morning) Low-volume Polyethylene Glycol Plus Bisacodyl Versus Split-dose Polyethylene Glycol for Bowel Preparation Efficacy in Patient Receiving Morning Colonoscopy
- ClinicalTrials.gov ID
- NCT03248726
- Acronym / sponsor ID
- N201610042
- Conditions
- Bowel Preparation
- Keywords
- Polyethylene Glycol, Bisacodyl, Colonoscopy, Bowel preparation, Ottawa bowel preparation scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Aug 2017 (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.
Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation which makes bowel preparation an important issue. Hence, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.
Detailed description
Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation. That makes bowel preparation an important issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and safety. However, there are many different adjunctive, dose, timing of administration in PEG preparation. Some may decrease patient tolerability due to large fluid volume, and some may influence patient's life and sleep quality when performing bowel preparation. Here, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol and bisacodyl | Experimental | Drug: Polyethylene glycol and bisacodylIn order to decrease the dose and frequency of polyethylene glycol, we added bisacodyl at the night before examination to facilitate the action of polyethylene glycol given solely in the morning of examination. |
| Split-dose polyethylene glycol | Active comparator | Drug: Split-dose polyethylene glycolThe standard regimen of polyethylene glycol was used in this group. The participant of this arm receives polyethylene glycol in the evening before examination and the morning of examination . |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20-70 years.
- Out-patient department ambulatory patient.
- Patients who have indications to receive colonoscopy.
Key exclusion criteria (9 listed)
- Age is under 20 or over 70
- Have severe renal impairment (hemodialysis or eGFR<30).
- Have severe congestive heart failure (NYHAⅢorⅣ).
- Pregnant or lactating, or women is under oral contraceptive.
- Have history of bowel obstruction or resection, known or suspected gastroparesis acute gastric/intestinal ulcer, toxic colitis or megacolon
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 |
|---|---|---|
| Polyethylene glycol and bisacodylAlso: Dulcolax®, Klean-prep®Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination. | Drug | Polyethylene glycol and bisacodyl |
| Split-dose polyethylene glycolAlso: Klean-prep®Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day. | Drug | Split-dose polyethylene glycol |
Primary outcome
The Ottawa Bowel Preparation Scale
Time frame: Within 24 hours after colonoscopy
Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as "good preparation".
1 secondary outcome
Life disturbance
Time frame: 30 minutes before patient receive colonoscopy
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 29 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Bowel Preparation
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
RecruitingPhase 4
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before 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.
Wei-Cheng Huang, Bachelor principal investigator
Gastroenterology division, Internal Medicine Department, Wanfang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene glycol and bisacodyl and Split-dose polyethylene glycol in people with Bowel Preparation, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 9 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 29 Oct 2019. 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 Taiwan. 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.
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?
The Ottawa Bowel Preparation Scale (time frame: Within 24 hours after colonoscopy). 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 29 Oct 2019.