Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04970277
Other study ID # 2021SDU-QILU-054
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 timeļ¼Œcompletion 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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT02158260 - A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy N/A
Completed NCT04605536 - Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy N/A
Completed NCT04327869 - MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract
Recruiting NCT03351972 - Differences in Preparation for Small Bowel Capsule Endoscopy Phase 4
Recruiting NCT01783782 - Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients Phase 4
Completed NCT04671264 - Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation N/A
Completed NCT03662113 - Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy N/A
Completed NCT03977935 - The Second-Generation MCCG for Upper Gastrointestinal Tract. N/A
Recruiting NCT03441945 - Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying N/A
Completed NCT04389333 - Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic N/A
Recruiting NCT04329468 - Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel N/A
Recruiting NCT04933643 - Analysis of Influencing Factors of Gastric Preparation Quality for MCCG
Completed NCT03482661 - Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate N/A
Completed NCT05073536 - Mini-sized MCE for Better Examination of UGI and Small Bowel N/A
Completed NCT03742934 - Short Peptide Formula for Bowel Preparation N/A
Completed NCT05228379 - Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre
Recruiting NCT05249933 - Pronase Granules in Gastric Cleaning Phase 2/Phase 3
Completed NCT02382705 - SB3 Battery Life Observational Study
Recruiting NCT04032353 - Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy N/A
Completed NCT04479423 - The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy N/A