Effect of Hp Infection on the Quality of Gastric Mucosa Preparation

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527496
• Other study ID #: individualliu
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2022
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Na Liu
• Phone: 18629082319
• Email: liunafmmu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Pylori Infection
• Infections

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to complete gastroscopy	The time from the start of the endoscopy to the complete removal of the endoscope	The day of gastroscopy
Secondary	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
Secondary	adverse reaction	Adverse reactions to study drugs, and respiratory, cardiovascular, or endoscopic adverse events.	Within 24 hours after endoscopy
Secondary	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