Efficacy of Drinking Water During Capsule Endoscopy

NCT ID: NCT04970277

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-18
• Study Completion Date: 2022-05-31

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.

Conditions

Capsule Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

drinking water group

Patients in this group drink colorless water after capsule ingestion.

Group Type: EXPERIMENTAL

drinking water group

Intervention Type: OTHER

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.

Group Type: OTHER

control group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

control group

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

doctoral supervisor of Qilu Hospital gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Zuo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong University Qilu hosipital, China

Locations

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuli Zuo, MD, PhD

Role: CONTACT

zuoxiuli@sdu.edu.cn

86 15588818685 ext. 0531-88369277

Facility Contacts

Xiuli Zuo, MD, PhD

Role: primary

zuoxiuli@sdu.edu.cn

86 15588818685 ext. 0531-88369277

Other Identifiers

2021SDU-QILU-054

Identifier Type: -

Identifier Source: org_study_id