- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340089
Squatting on the Toilet and Capsule Endoscopy (SC)
April 13, 2020 updated by: The Second Affiliated Hospital of Chongqing Medical University
The Effect of Squatting on the Toilet on Gastric Transit Time and Complete Examination Rate of Capsule Endoscopy
This study evaluates the effect of squatting on the toilet on gastric transit time and complete examination rate of capsule endoscopy.In the observation group, the patients could go to squatting on the toilet at any time as they want to after taking the capsule.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The subjects were divided into a control group and an observation group according to whether the patient squatted in the toilet, In the control group, the patients took discontinuous right lateral position, walked on a flat road and climbed the stairs alternately.
In the observation group, in addition to the above ways, the patients could go to squatting on the toilet at any time in the first hour after taking the capsule.
The operator observed the position of capsule every one hour.
The examination was over when capsule endoscopy entered the colon.
If the capsule remained in the small intestine, the examination continued until the capsule ran out of power.
Study Type
Observational
Enrollment (Anticipated)
300
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
-
-
Chongqing
-
Chongqing, Chongqing, China, 400010
- The Second Affiliated Hospital of Chongqing Medical University
-
-
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
8 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
the patients needed to the examination of capsule endoscopy.
Description
Inclusion Criteria:
- unexplained gastrointestinal bleeding, unexplained chronic abdominal pain and diarrhea, suspected Crohn's disease, suspected small intestinal tumor, and patients needing to exclude small intestinal diseases.
Exclusion Criteria:
- suspected intestinal obstruction and intestinal stenosis, esophageal stenosis or dysphagia, history of abdominal operation, or diabetes mellitus.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
observation group
the patients can go to squatting on the toilet at any time as they want to after taking the capsule
|
the patients could go to squatting on the toilet at any time as they want to after taking the capsule
|
control group
The patients can move freely
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CER
Time Frame: 72 hours
|
complete examination rate
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GTT
Time Frame: 72 hours
|
gastric transit time
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Song He, Dr., director of department
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 (Anticipated)
April 15, 2020
Primary Completion (Anticipated)
September 30, 2021
Study Completion (Anticipated)
March 31, 2022
Study Registration Dates
First Submitted
April 7, 2020
First Submitted That Met QC Criteria
April 7, 2020
First Posted (Actual)
April 9, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 13, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- wuzhixuan2003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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