Bowel PreparationNCT06000241
Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation for Colonoscopy Under Anesthesia
An observational study of Bowel Preparation, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
220 patients are allocated randomly to the morning group (am group) or the afternoon group (pm group) and assessed by quality of bowel preparation and residual volume gastric residue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation
- How many people
- 220 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2021to 1 Jul 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants have a cluster of elective EGD and colonoscopy under anesthesia.
Who may be able to join
- Patients are able to follow the instructions of bowel preparation and have good ability of walking at least an hour.
Who cannot join
- Clinical diagnosis of obstruction of bowel and sever renal and heart disease.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical Hospital
Beijing, Beijing Municipality, 100730
Peking Union Medical College Hospital
Beijing
About this study
Official title: Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation Under Anesthesia
220 patients are allocated randomly to the morning group (am group) or the afternoon group (pm group) and assessed by quality of bowel preparation and residual volume gastric residue.
- Conditions
- Bowel Preparation
What is being measured
The primary outcome is the main question the study is designed to answer.
ottawa score
Two nurses observe cleaning of three parts of colon and give a score for each.
Measured: a day
gastric residual volume
Gastric contents are suctioned and measured.
Measured: 30 minutes
colonic residual volume
Colonic fluids are suctioned and measured.
Measured: 30 minutes
Secondary outcomes (2)
reflux
incidence of reflux during both the EGD and colonoscopy
Measured: 60mins
adenoma detection rate
percentages of patients screened with colonic adenoma in total patients
Measured: a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2021
- Primary completion15 Jun 2023
- Study completion1 Jul 2023
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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000241
- Sponsor's protocol ID
- JS-3388
- Status last verified
- Mar 2023
- First submitted
- 14 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation Under Anesthesia
- ClinicalTrials.gov ID
- NCT06000241
- Acronym / sponsor ID
- JS-3388
- Conditions
- Bowel Preparation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (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.
220 patients are allocated randomly to the morning group (am group) or the afternoon group (pm group) and assessed by quality of bowel preparation and residual volume gastric residue.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants have a cluster of elective EGD and colonoscopy under anesthesia.
Key inclusion criteria (1 listed)
- Patients are able to follow the instructions of bowel preparation and have good ability of walking at least an hour.
Key exclusion criteria (1 listed)
- Clinical diagnosis of obstruction of bowel and sever renal and heart disease.
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 score
Time frame: a day
Two nurses observe cleaning of three parts of colon and give a score for each.
gastric residual volume
Time frame: 30 minutes
Gastric contents are suctioned and measured.
colonic residual volume
Time frame: 30 minutes
Colonic fluids are suctioned and measured.
2 secondary outcomes
reflux
Time frame: 60mins
adenoma detection rate
Time frame: a day
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 21 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Preparation, run by Peking Union Medical College Hospital at 2 sites 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 1 inclusion and 1 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
ottawa score (time frame: a day). The study lists 3 primary outcomes in all. 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 21 Aug 2023.