NCT04970277

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

July 18, 2021

Last Update Submit

May 1, 2022

Conditions

Capsule Endoscopy

Keywords

Capsule endoscopy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • complete examination rate of the small bowel

    3 months

  • image quality

    3 months

  • diagnostic yields

    3 months

Study Arms (2)

drinking water group

EXPERIMENTAL

Patients in this group drink colorless water after capsule ingestion.

Other: drinking water group

control group

OTHER

Patients in this group don't drink colorless water after capsule ingestion.

Other: control group

Interventions

drinking water groupOTHER

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.

drinking water group
control groupOTHER

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

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years undergoing capsule endoscopy

You may not qualify if:

  • Patients with suspected intestinal obstruction, intestinal diverticulum, stricture or fistula
  • previous gastric or small-bowel surgery
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Xiuli Zuo, MD, PhD

    Shandong University Qilu hosipital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD, PhD

CONTACT

86 15588818685zuoxiuli@sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral supervisor of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

July 18, 2021

First Posted

July 21, 2021

Study Start

July 18, 2021

Primary Completion

April 6, 2022

Study Completion

May 1, 2022

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations

CN(1)