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CompletedNCT05101395Updated Nov 8, 2021

Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens

An observational study in Gastritis H Pylori, Gastritis and Obesity Associated Disorder, sponsored by University of Jordan. Completed at 1 site in Jordan. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.

Sponsored by University of Jordan · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
810
Ages
12 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Gastritis H Pylori
  • Gastritis
  • Obesity Associated Disorder

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Keywords

  • Histopathology
  • Sleeve gastrectomy
  • LSG
  • Gastritis
  • H. Pylori
  • Jordan
  • Middle East
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In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's enrollment of 810 is above the median of 400 across 79 observational studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

University of Jordan is the lead sponsor of 126 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Obese patients who undergo sleeve gastrectomy for bariatric reasons

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients whose resected specimens were not examined histopathologically
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
810 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with Gastritis

    Patients who underwent sleeve gastrectomy and the histopathology result of resected gastric specimen showed the presence of gastritis in it.

    Other: Giemsa stain

Interventions

  • OtherGiemsa stain

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

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What researchers measure

Primary outcomes

  1. Prevalence of gastritis

    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)

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

  2. Prevalence of H.pylori gastritis

    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)

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

Secondary outcomes

  1. Prevalence of other histopathological findings

    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)

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

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

    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.

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

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

    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.

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

  4. likelihood ratio between H.pylori gastritis and BMI

    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.

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

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Study locations

1 site
  • Jordan University Hospital
    Amman, Jubaiha 13046, Jordan
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References and documents

Publications

  • Boliko MC. FAO and the Situation of Food Security and Nutrition in the World. J Nutr Sci Vitaminol (Tokyo). 2019;65(Supplement):S4-S8. doi: 10.3177/jnsv.65.S4. PubMed 31619643 ↗
  • Ge L, Moon RC, Nguyen H, de Quadros LG, Teixeira AF, Jawad MA. Pathologic findings of the removed stomach during sleeve gastrectomy. Surg Endosc. 2019 Dec;33(12):4003-4007. doi: 10.1007/s00464-019-06689-y. Epub 2019 Feb 15. PubMed 30771070 ↗
  • Rosenthal RJ; International Sleeve Gastrectomy Expert Panel; Diaz AA, Arvidsson D, Baker RS, Basso N, Bellanger D, Boza C, El Mourad H, France M, Gagner M, Galvao-Neto M, Higa KD, Himpens J, Hutchinson CM, Jacobs M, Jorgensen JO, Jossart G, Lakdawala M, Nguyen NT, Nocca D, Prager G, Pomp A, Ramos AC, Rosenthal RJ, Shah S, Vix M, Wittgrove A, Zundel N. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis. 2012 Jan-Feb;8(1):8-19. doi: 10.1016/j.soard.2011.10.019. Epub 2011 Nov 10. PubMed 22248433 ↗
  • Abd Ellatif ME, Abdallah E, Askar W, Thabet W, Aboushady M, Abbas AE, El Hadidi A, Elezaby AF, Salama AF, Dawoud IE, Moatamed A, Wahby M. Long term predictors of success after laparoscopic sleeve gastrectomy. Int J Surg. 2014;12(5):504-8. doi: 10.1016/j.ijsu.2014.02.008. Epub 2014 Feb 18. PubMed 24560848 ↗
  • Safaan T, Bashah M, El Ansari W, Karam M. Histopathological Changes in Laparoscopic Sleeve Gastrectomy Specimens: Prevalence, Risk Factors, and Value of Routine Histopathologic Examination. Obes Surg. 2017 Jul;27(7):1741-1749. doi: 10.1007/s11695-016-2525-1. Erratum In: Obes Surg. 2017 Oct;27(10):2778. doi: 10.1007/s11695-017-2819-y. PubMed 28063114 ↗
  • Yardimci E, Bozkurt S, Baskoy L, Bektasoglu HK, Gecer MO, Yigman S, Akbulut H, Coskun H. Rare Entities of Histopathological Findings in 755 Sleeve Gastrectomy Cases: a Synopsis of Preoperative Endoscopy Findings and Histological Evaluation of the Specimen. Obes Surg. 2018 May;28(5):1289-1295. doi: 10.1007/s11695-017-3014-x. PubMed 29151240 ↗
  • Miller GC, Reid AS, Brown IS. The pathological findings seen in laparoscopic sleeve gastrectomies for weight loss. Pathology. 2016 Apr;48(3):228-32. doi: 10.1016/j.pathol.2015.12.449. Epub 2016 Mar 8. PubMed 27020497 ↗
  • F. Obeidat, A. Shahait, H. Shanti, H. Al-Momani, and S. Abu Halaweh, "Histopathology results of Jordanian patients after laparoscopic sleeve gastrectomy," Saudi J. Obes., vol. 3, no. 1, p. 18, 2015, doi: 10.4103/2347-2618.158693
  • Deitel M, Gagner M, Erickson AL, Crosby RD. Third International Summit: Current status of sleeve gastrectomy. Surg Obes Relat Dis. 2011 Nov-Dec;7(6):749-59. doi: 10.1016/j.soard.2011.07.017. Epub 2011 Aug 10. PubMed 21945699 ↗
  • Agha R, Abdall-Razak A, Crossley E, Dowlut N, Iosifidis C, Mathew G; STROCSS Group. STROCSS 2019 Guideline: Strengthening the reporting of cohort studies in surgery. Int J Surg. 2019 Dec;72:156-165. doi: 10.1016/j.ijsu.2019.11.002. Epub 2019 Nov 6. PubMed 31704426 ↗
  • Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0. PubMed 23338049 ↗
  • Angrisani L, Santonicola A, Iovino P, Formisano G, Buchwald H, Scopinaro N. Bariatric Surgery Worldwide 2013. Obes Surg. 2015 Oct;25(10):1822-32. doi: 10.1007/s11695-015-1657-z. PubMed 25835983 ↗
  • Angrisani L, Santonicola A, Iovino P, Vitiello A, Zundel N, Buchwald H, Scopinaro N. Bariatric Surgery and Endoluminal Procedures: IFSO Worldwide Survey 2014. Obes Surg. 2017 Sep;27(9):2279-2289. doi: 10.1007/s11695-017-2666-x. Erratum In: Obes Surg. 2017 Sep;27(9):2290-2292. doi: 10.1007/s11695-017-2773-8. PubMed 28405878 ↗
  • B. A. Hussein, A. Khammas, J. Anglo, A. Al Mazrouei, and F. Badri, "Is Histopathology Needed after Sleeve Gastrectomy?," J. Am. Coll. Surg., vol. 227, no. 4, p. e71, 2018, doi: 10.1016/j.jamcollsurg.2018.08.192
  • Al Saady R, Ejeckam G. Histopathological findings in laparoscopic sleeve gastrectomy specimens. Qatar Med J. 2019 Jul 25;2019(1):5. doi: 10.5339/qmj.2019.5. eCollection 2019. PubMed 31384574 ↗
  • S. R. Shikha Jain, "Histopathological Spectrum of Laparoscopic Sleeve Gastrectomies: A Retrospective Study," Indian J Pathol Res Pr., vol. 8, no. 2, pp. 223-228, 2019, doi: http://dx.doi.org/10.21088/ijprp.2278.148X.8219.16.

Individual participant data

Plan to share: Undecided — We are not willing to share study data due to hospital policies, but data is available for interested researchers upon request after verification and masking through corresponding author.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05101395
Lead sponsor
University of Jordan
Responsible party
Hanan Ibrahim Mansour (Senior General Surgery Resident, University of Jordan) — Principal investigator
First posted
Nov 1, 2021
Start date
Jan 1, 2015
Primary completion
Oct 30, 2019
Completion
Oct 30, 2019
Last update
Nov 8, 2021

Study contacts

Raed Al-Taher, M.D.
study director · Jordan University Hospital
Mohammad Z Rashdan, M.D.
principal investigator · Jordan University Hospital
Firas I Obeidat, Prof.
study chair · Jordan University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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