Bowel Preparation Before ColonoscopyNCT05498714
Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation
A study testing PEG+lactulose and CSP＋lactulose in people with Bowel Preparation Before Colonoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The purpose of this study is to observe the difference in bowel preparation quality between compound sodium picosulfate#CSP combined with lactulose and polyethylene glycol electrolyte#PEG combined with lactulose in high-risk population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation Before Colonoscopy
- What is being tested?
- PEG+lactulose and CSP＋lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2022to 30 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
- Patients with galactosemia;
- hypersensitivity to any of the ingredients;
- Pregnancy or lactation;
- Use of lactulose,prokinetic agents or purgatives within 7 days;
- Unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
About this study
Official title: Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation#a Single-center,Endoscopist-blinded Randomized Controlled Trial
The purpose of this study is to observe the difference in bowel preparation quality between compound sodium picosulfate#CSP combined with lactulose and polyethylene glycol electrolyte#PEG combined with lactulose in high-risk population.
Read the detailed description
The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age >70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors.This is a single-center ,endoscopist-blinded study to compare the efficacy of CSP combined with lactulose and PEG combined with lactulose in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.
- Conditions
- Bowel Preparation Before Colonoscopy
- Being tested
- PEG+lactulose, CSP＋lactulose
- Keywords
- Colonoscopy, Bowel Preparation, Polyethylene glycol, Compound Sodium Picosulfate, Lactulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG+lactuloseDrug
Also called PEG combined with lactulose
On the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM. On the day of the procedure, patients took 50 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.
CSP＋lactuloseDrug
Also called CSP combined with lactulose
On the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 150 mL of CSP at 8:00 PM ,followed by 2000ml of clarified liquid. On the day of the procedure, 4-6 hours before colonoscopy, patients took 50 mL lactulose solution and the remaining 150mL of CSP ,then followed by 750ml of clarified liquid .
| Study group | Role | What they receive |
|---|---|---|
| the control group | Active comparator | The dosing regimen of high-risk patients will be PEG combined with lactulose. Receives: Drug: PEG+lactulose |
| CSP+lactulose group | Experimental | The dosing regimen of high-risk patients will be CSP combined with lactulose. Receives: Drug: CSP＋lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale
Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2, we regard it as adequate bowel preparation.
Measured: during colonoscopy
Secondary outcomes (8)
Adenoma Detection Rate
Diagnosis was confirmed by histologic examination
Measured: 2 days
Polyp Detection Rate
Diagnosis was confirmed by histologic examination
Measured: 2 days
Rate of adverse events
adverse events, such as vomiting, nausea, headache, abdominal distention, abdominal pain.
Measured: 2 days
Cecal intubation rate
Colonoscopy reaches cecal region.
Measured: during colonoscopy
Cecal intubation time
Colonoscopy reaches cecal region.
Measured: during colonoscopy
Withdrawal time
The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.
Measured: during colonoscopy
defecation frequency
Frequency of bowel movement.
Measured: 2 days
patient satisfaction Assessment
Patients' satisfaction score for bowel preparation (3 points: completely tolerable and very satisfied; 2 points: nausea and other discomfort, but still tolerable and satisfactory; 1: unable to tolerate, not satisfied);
And whether the patient is willing to use the bowel cleansing program for colonoscopy;
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start18 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation Before ColonoscopyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
- Investigators
- Mingkai Chen, Ph.D & M.D, Study director, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498714
- Sponsor's protocol ID
- WDRY2022-K082
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation#a Single-center,Endoscopist-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05498714
- Acronym / sponsor ID
- WDRY2022-K082
- Conditions
- Bowel Preparation Before Colonoscopy
- Keywords
- Colonoscopy, Bowel Preparation, Polyethylene glycol, Compound Sodium Picosulfate, Lactulose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 Aug 2022 (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.
The purpose of this study is to observe the difference in bowel preparation quality between compound sodium picosulfate#CSP combined with lactulose and polyethylene glycol electrolyte#PEG combined with lactulose in high-risk population.
Detailed description
The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age >70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors.This is a single-center ,endoscopist-blinded study to compare the efficacy of CSP combined with lactulose and PEG combined with lactulose in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | Active comparator | Drug: PEG+lactuloseThe dosing regimen of high-risk patients will be PEG combined with lactulose. |
| CSP+lactulose group | Experimental | Drug: CSP＋lactuloseThe dosing regimen of high-risk patients will be CSP combined with lactulose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
- Patients with galactosemia;
- hypersensitivity to any of the ingredients;
- Pregnancy or lactation;
- Use of lactulose,prokinetic agents or purgatives within 7 days;
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 |
|---|---|---|
| PEG+lactuloseAlso: PEG combined with lactuloseOn the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM. On the day of the procedure, patients took 50 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy. | Drug | the control group |
| CSP＋lactuloseAlso: CSP combined with lactuloseOn the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 150 mL of CSP at 8:00 PM ,followed by 2000ml of clarified liquid. On the day of the procedure, 4-6 hours before colonoscopy, patients took 50 mL lactulose solution and the remaining 150mL of CSP ,then followed by 750ml of clarified liquid . | Drug | CSP+lactulose group |
Primary outcome
Boston Bowel Preparation Scale
Time frame: during colonoscopy
Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2, we regard it as adequate bowel preparation.
8 secondary outcomes
Adenoma Detection Rate
Time frame: 2 days
Polyp Detection Rate
Time frame: 2 days
Rate of adverse events
Time frame: 2 days
Cecal intubation rate
Time frame: during colonoscopy
Cecal intubation time
Time frame: during colonoscopy
Withdrawal time
Time frame: during colonoscopy
defecation frequency
Time frame: 2 days
patient satisfaction Assessment
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Mingkai Chen, Ph.D & M.D study director
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG+lactulose and CSP＋lactulose in people with Bowel Preparation Before Colonoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.
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 0 inclusion and 6 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 Aug 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingkai Chen, Ph.D & M.D (13720330580, chenmingkai@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (time frame: during 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 25 Aug 2022.