Efficacy of Drinking Water During Capsule Endoscopy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Capsule Endoscopy
• Intervention / Treatment: Other: drinking water group; Other: control group

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastric transit time	the time between the first gastric image and the first duodenal image	3 months
small-bowel transit time	the imaging time of capsule endoscopy in the small bowel	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete examination rate of the small bowel	the percentage of patients with complete examination of the small bowel in each group	3 months
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
diagnostic yields	Clinical diagnoses made by the capsule endoscopy were recorded for each patient.	3 months

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Xiuli Zuo, MD, PhD, Shandong University Qilu hosipital, China

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2021
• Primary Completion (Actual): April 6, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Capsule endoscopy
• Other Study ID Numbers: 2021SDU-QILU-054

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No