Effect of Hp Infection on the Quality of Gastric Mucosa Preparation

Effect of Hp Infection on the Quality of Gastric Mucosa Preparation and Study on Different Gastric Mucosa Preparation Schemes in Patients With Hp Infection

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

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection

Detailed Description

The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation by comparing the cleanliness of gastric mucosa between patients with Helicobacter pylori infection and those without Helicobacter pylori infection.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Na Liu; Phone Number: 18629082319; Email: liunafmmu@163.com
• Study Contact Backup: Name: X Li; Phone Number: 15319052748; Email: 3284519464@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • The Second Affiliated Hospital of Xi 'an Jiaotong University
      • Contact: Na Liu; Phone Number: 18629082319; Email: liunafmmu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All outpatients or inpatients requiring general gastroscopy

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete gastroscopy	The time from the start of the endoscopy to the complete removal of the endoscope	The day of gastroscopy
Patient comfort score	Prior to endoscopy, the patient was instructed to indicate the level of discomfort on a visual analogue scale, which was rated by the patient on a scale of 0 to 10, with 0 indicating no discomfort and 10 indicating maximum discomfort.	Records were made on the 1 day of the gastroscopy
adverse reaction	Adverse reactions to study drugs, and respiratory, cardiovascular, or endoscopic adverse events.	Within 24 hours after endoscopy
Endoscopic findings	The diagnostic results were recorded under gastroscopy, and if the biopsy was taken under gastroscopy, the pathological results were also recorded	About 15 days after endoscopy

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: individualliu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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