NCT05527496

Brief Summary

The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

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

Study Start

First participant enrolled

August 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

August 31, 2022

Last Update Submit

September 1, 2022

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • Cleanliness of gastric mucosa

    The visibility of gastric mucosa was scored for four parts of the stomach (antrum, upper body, lower body and fundus).

    The time the patient underwent gastroscopy procedure

Secondary Outcomes (4)

  • Time to complete gastroscopy

    The day of gastroscopy

  • Patient comfort score

    Records were made on the 1 day of the gastroscopy

  • adverse reaction

    Within 24 hours after endoscopy

  • Endoscopic findings

    About 15 days after endoscopy

Study Arms (2)

Patients with Helicobacter pylori infection

Patients with H. pylori infection identified by testing for H. pylori.

Patients not infected with Helicobacter pylori

Patients without H. pylori infection identified by H. pylori testing.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All outpatients or inpatients requiring general gastroscopy

You may qualify if:

  • Adults who volunteered to participate in this study and signed an informed consent form
  • Have been tested for Helicobacter pylori and have definite test results

You may not qualify if:

  • Contraindications for gastroscopy (such as severe cardiopulmonary diseases, liver and kidney dysfunction, shock, etc.)
  • History of upper gastrointestinal surgery
  • Therapeutic endoscopy and emergency surgery are required
  • Recent history of upper gastrointestinal bleeding
  • Corrosive substance ingestion
  • The pregnancy
  • Abnormal mental state cannot cooperate with the examination
  • Patients with contraindications to the drugs used in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710000, China

RECRUITING

Central Study Contacts

Na Liu

CONTACT

18629082319liunafmmu@163.com

X Li

CONTACT

153190527483284519464@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 31, 2023

Last Updated

September 2, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)