SC: Squatting on the Toilet and Capsule Endoscopy

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04340089
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Diseases	Behavioral: squatting on the toilet

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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effect of Squatting on the Toilet on Gastric Transit Time and Complete Examination Rate of Capsule Endoscopy
• Anticipated Study Start Date: Apr 15, 2020
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
observation group the patients can go to squatting on the toilet at any time as they want to after taking the capsule	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
control group The patients can move freely

Outcome Measures

Primary Outcome Measures

1. CER [72 hours]

   complete examination rate

Secondary Outcome Measures

1. GTT [72 hours]

   gastric transit time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital of Chongqing Medical University	Chongqing	Chongqing	China	400010

Sponsors and Collaborators

• The Second Affiliated Hospital of Chongqing Medical University

Investigators

• Principal Investigator: Song He, Dr., Director of department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Affiliated Hospital of Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT04340089
• Other Study ID Numbers: wuzhixuan2003
• First Posted: Apr 9, 2020
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Second Affiliated Hospital of Chongqing Medical University: squatting on the toilet; capsule endoscopy
• Additional relevant MeSH terms: Intestinal Diseases

Study Results

No Results Posted as of Apr 14, 2020