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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04340089
Other study ID # wuzhixuan2003
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date March 31, 2022

Study information

Verified date April 2020
Source The Second Affiliated Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date March 31, 2022
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
squatting on the toilet
the patients could go to squatting on the toilet at any time as they want to after taking the capsule

Locations

Country Name City State
China The second affiliated hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CER complete examination rate 72 hours
Secondary GTT gastric transit time 72 hours
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