Efficacy of Drinking Water During Capsule Endoscopy

Not Applicable

• Conditions: Capsule Endoscopy

• Registration Number: NCT04970277
• Lead Sponsor: Shandong University

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.

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 Timeline

• Study Start: 2021-07-18
• Study First Submitted: 2021-07-18
• Study First Submitted QC: 2021-07-18
• Study First Posted: 2021-07-21
• Status Verified: 2022-04
• Primary Completion: 2022-04-06
• Study Completion: 2022-05
• Last Update Submitted: 2022-05-01
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
gastric transit time	3 months	the time between the first gastric image and the first duodenal image
small-bowel transit time	3 months	the imaging time of capsule endoscopy in the small bowel

Secondary Outcome Measures

Name	Time	Method
diagnostic yields	3 months	Clinical diagnoses made by the capsule endoscopy were recorded for each patient.
complete examination rate of the small bowel	3 months	the percentage of patients with complete examination of the small bowel in each group
image quality	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.

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China