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Completed

NCT Number: NCT05101395

Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens

This is a cross-sectional study looking for prevalence of H.Pylori related gastritis among patients underwent sleeve gastrectomy over five year study period. The study also looks for possible association with patients's characteristics. Also, compares its findings with similar regional and international studies.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jordan University Hospital

Amman, Jubaiha, 13046, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who underwent sleeve gastrectomy
  • surgery was performed between January 2015 and October 2019

Exclusion criteria

  • patients whose resected specimens were not examined histopathologically

Treatment and study plan

Giemsa stain

Other

Giemsa special stain was employed for detection of H. Pylori microorganisms.

Primary outcomes

  1. Prevalence of gastritis

    Time frame: start to end of the study, 5 years

    proportion of patients who underwent sleeve gastrectomy who have gastritis in their resected gastric specimen at or during study period.

    calculated as (number of pt with gastritis / number of examined resected gastric specimens)

  2. Prevalence of H.pylori gastritis

    Time frame: start to end of the study, 5 years

    proportion of patients who underwent sleeve gastrectomy who have H.pylori related gastritis in their resected gastric specimen at or during study period.

    calculated as (number of pt with H.pylori gastritis / number of examined resected gastric specimens)

Secondary outcomes

  1. Prevalence of other histopathological findings

    Time frame: start to end of the study, 5 years

    proportion of patients who underwent sleeve gastrectomy who have histopathological findings not including gastritis or H.pylori related gastritis in their resected gastric specimen at or during study period.

    calculated as (number of pt with the histopathological finding / number of examined resected gastric specimens)

  2. likelihood ratio between H.pylori gastritis and advancing age

    Time frame: start to end of the study, 5 years

    The relationship between H.pylori gastritis and advancing age. likelihood ratio will be calculated by cross table analysis using Statistical Analysis Software SPSS program version 26.

  3. likelihood ratio between H.pylori gastritis and female gender

    Time frame: start to end of the study, 5 years

    The relationship between H.pylori gastritis and female gender. likelihood ratio will be calculated by cross table analysis using Statistical Analysis Software SPSS program version 26.

  4. likelihood ratio between H.pylori gastritis and BMI

    Time frame: start to end of the study, 5 years

    The relationship between H.pylori gastritis and body mass index (BMI). weight and height will be combined to report BMI in kg/m^2 likelihood ratio will be calculated by cross table analysis looking for using Statistical Analysis Software SPSS program version 26.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens: A Cross-Sectional

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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