NCT05101395

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
810

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

4.8 years

First QC Date

October 19, 2021

Last Update Submit

October 30, 2021

Conditions

Gastritis H PyloriGastritisObesity Associated Disorder

Keywords

HistopathologySleeve gastrectomyLSGGastritisH. PyloriJordanMiddle East

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Prevalence of other histopathological findings

    start to end of the study, 5 years

  • likelihood ratio between H.pylori gastritis and advancing age

    start to end of the study, 5 years

  • likelihood ratio between H.pylori gastritis and female gender

    start to end of the study, 5 years

  • likelihood ratio between H.pylori gastritis and BMI

    start to end of the study, 5 years

Study Arms (1)

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

Giemsa stainOTHER

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

Patients with Gastritis

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Obese patients who undergo sleeve gastrectomy for bariatric reasons

You may qualify if:

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

You may not qualify if:

  • patients whose resected specimens were not examined histopathologically

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University Hospital

Amman, Jubaiha, 13046, Jordan

Location

Related Publications (16)

  • 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.

    PMID: 31619643BACKGROUND

  • 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.

    PMID: 30771070BACKGROUND

  • 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.

    PMID: 22248433BACKGROUND

  • 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.

    PMID: 24560848BACKGROUND

  • 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.

    PMID: 28063114BACKGROUND

  • 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.

    PMID: 29151240BACKGROUND

  • 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.

    PMID: 27020497BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 21945699BACKGROUND

  • 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.

    PMID: 31704426BACKGROUND

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

    PMID: 23338049BACKGROUND

  • 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.

    PMID: 25835983BACKGROUND

  • 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.

    PMID: 28405878BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 31384574BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Gastritis

Interventions

Azure Stains

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Raed Al-Taher, M.D.

    Jordan University Hospital

    STUDY DIRECTOR

  • Mohammad Z Rashdan, M.D.

    Jordan University Hospital

    PRINCIPAL INVESTIGATOR

  • Firas I Obeidat, Prof.

    Jordan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior General Surgery Resident

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 1, 2021

Study Start

January 1, 2015

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

November 8, 2021

Record last verified: 2021-10

Locations

JO(1)