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Efficacy of Drinking Water During Capsule Endoscopy

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ClinicalTrials.gov Identifier: NCT04970277
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Study Description
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Brief Summary:
The aims of this study are to evaluate the effect of early drinking water after the capsule ingestion on the gastrointestinal transit and image quality of capsule endoscopy.

Condition or disease Intervention/treatment Phase
Capsule Endoscopy Other: drinking water group Other: control group Not Applicable

Detailed Description:
Capsule endoscopy has been a significant technologic advancement that has allowed the direct examination of mucosa throughout the entire small intestine in a noninvasive fashion; and it has become the primary technique for imaging the small bowel. However, as imaging time is limited to about 8 hours, a prolonged transit of the capsule endoscope in the stomach may result in an incomplete small bowel transit (i.e. failure of the capsule to reach the cecum). Delayed transit time of stomach may be responsible for the failure of capsule endoscopy to visualize the distal portions of the small bowel, and potentially may result in the inability to identify small-bowel pathology in these areas. Previous study showed that drinking water might improve completion rate of capsule endoscopy. And bowel preparation of clear liquids may improve image quality of small bowel mucosa. The aim of this study was to assess the effect of drinking water on the transit time，completion rate and image quality of capsule endoscopy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Efficacy of Drinking Water on Transit Time and Complete Examination Rate During Capsule Endoscopy
Actual Study Start Date : July 18, 2021
Actual Primary Completion Date : April 6, 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: drinking water group
Patients in this group drink colorless water after capsule ingestion.
 Other: drinking water group
Those randomized to drink water group were asked to drink 200 mL colorless water every 10 minutes, starting at the time of capsule ingestion until three times in total.
control group
Patients in this group don't drink colorless water after capsule ingestion.
 Other: control group
Those randomized to control group were asked not to drink extra water after capsule ingestion.


Outcome Measures
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Primary Outcome Measures :
  1. gastric transit time [ Time Frame: 3 months ]
    the time between the first gastric image and the first duodenal image

  2. small-bowel transit time [ Time Frame: 3 months ]
    the imaging time of capsule endoscopy in the small bowel


Secondary Outcome Measures :
  1. complete examination rate of the small bowel [ Time Frame: 3 months ]
    the percentage of patients with complete examination of the small bowel in each group

  2. image quality [ Time Frame: 3 months ]
    The scale was based on the uncovered image area percentage (0, 0%-20%; 1, 20%-40%; 3, 60%-80%; 4, 80%-100%). The image quality was based on the mean of 5-min scores and higher scores mean a better outcome.

  3. diagnostic yields [ Time Frame: 3 months ]
    Clinical diagnoses made by the capsule endoscopy were recorded for each patient.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients aged 18-80 years undergoing capsule endoscopy

Exclusion Criteria:

  1. Patients with suspected intestinal obstruction, intestinal diverticulum, stricture or fistula
  2. previous gastric or small-bowel surgery
  3. pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04970277


Contacts
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Contact: Xiuli Zuo, MD, PhD 86 15588818685 ext 0531-88369277 zuoxiuli@sdu.edu.cn

Locations
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China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Xiuli Zuo, MD, PhD    86 15588818685 ext 0531-88369277    zuoxiuli@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, MD, PhD Shandong University Qilu hosipital, China
More Information
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Responsible Party: Xiuli Zuo, doctoral supervisor of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier: NCT04970277    
Other Study ID Numbers: 2021SDU-QILU-054
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuli Zuo, Shandong University:
Capsule endoscopy