Efficacy of Drinking Water During Capsule Endoscopy

Capsule Endoscopy Clinical Trial

Official title:

Efficacy of Drinking Water on Transit Time and Complete Examination Rate During Capsule Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970277
• Other study ID #: 2021SDU-QILU-054
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2021
• Est. completion date: May 2022

Study information

• Verified date: April 2022
• Source: Shandong University
• Contact: Xiuli Zuo, MD, PhD
• Phone: 86 15588818685
• Email: zuoxiuli[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

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
Those randomized to control group were asked not to drink extra water after capsule ingestion.

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastric transit time	the time between the first gastric image and the first duodenal image	3 months
Primary	small-bowel transit time	the imaging time of capsule endoscopy in the small bowel	3 months
Secondary	complete examination rate of the small bowel	the percentage of patients with complete examination of the small bowel in each group	3 months
Secondary	image quality	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 months
Secondary	diagnostic yields	Clinical diagnoses made by the capsule endoscopy were recorded for each patient.	3 months