Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens

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

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.

Study Overview

• Status: Completed
• Conditions: Gastritis; Obesity Associated Disorder; Gastritis H Pylori
• Intervention / Treatment: Other: Giemsa stain

• Study Type: Observational
• Enrollment (Actual): 810

Contacts and Locations

Study Locations

• Jordan
  • Jubaiha
    • Amman, Jubaiha, Jordan, 13046
      • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Obese patients who undergo sleeve gastrectomy for bariatric reasons

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Giemsa special stain was employed for detection of H. Pylori microorganisms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	start to end of the study, 5 years
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)	start to end of the study, 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	start to end of the study, 5 years
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.	start to end of the study, 5 years
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.	start to end of the study, 5 years
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.	start to end of the study, 5 years

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Study Director: Raed Al-Taher, M.D., Jordan University Hospital; Principal Investigator: Mohammad Z Rashdan, M.D., Jordan University Hospital; Study Chair: Firas I Obeidat, Prof., Jordan University Hospital

Publications and helpful links

General Publications

• 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 Jul 5;:
• Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 Jul 27;:
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 30, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Gastritis; Sleeve gastrectomy; Histopathology; Jordan; H. Pylori; LSG; Middle East
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: 10/2020/8972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

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