- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06000241
Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation for Colonoscopy Under Anesthesia
August 14, 2023 updated by: Peking Union Medical College Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Peking Union Medical College Hospital
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Peking Union Medical Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants have a cluster of elective EGD and colonoscopy under anesthesia.
Description
Inclusion Criteria:
Patients are able to follow the instructions of bowel preparation and have good ability of walking at least an hour.
Exclusion Criteria:
Clinical diagnosis of obstruction of bowel and sever renal and heart disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ottawa score
Time Frame: a day
|
Two nurses observe cleaning of three parts of colon and give a score for each.
|
a day
|
gastric residual volume
Time Frame: 30 minutes
|
Gastric contents are suctioned and measured.
|
30 minutes
|
colonic residual volume
Time Frame: 30 minutes
|
Colonic fluids are suctioned and measured.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reflux
Time Frame: 60mins
|
incidence of reflux during both the EGD and colonoscopy
|
60mins
|
adenoma detection rate
Time Frame: a day
|
percentages of patients screened with colonic adenoma in total patients
|
a day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
June 15, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
August 14, 2023
First Submitted That Met QC Criteria
August 14, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- JS-3388
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bowel Preparation
-
University of British ColumbiaCompletedEfficacy of Bowel Preparation | Ease of Bowel Preparation and Patient TolerabilityCanada
-
Alexandra Hospital, Athens, GreeceRecruitingBowel Preparation | Preparation for ColonoscopyGreece
-
Inje UniversityUnknownBOWEL PREPARATION (BOWEL CLEANSING)Korea, Republic of
-
Jinling Hospital, ChinaRecruiting
-
Ferring PharmaceuticalsRecruitingBowel PreparationUnited States
-
Taejoon Pharmaceutical Co., Ltd.Completed
-
Azienda USL ModenaCompleted
-
Shandong UniversityUnknownBowel PreparationChina
-
Samsung Medical CenterCompletedBowel PreparationKorea, Republic of