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Gastritis H PyloriNCT05101395

Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens

An observational study of Gastritis H Pylori and Gastritis, run by University of Jordan at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Giemsa stain
How many people
810 participants
Where
1 siteJordan
Study dates
1 Jan 2015to 30 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Obese patients who undergo sleeve gastrectomy for bariatric reasons

Who may be able to join

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

Who cannot join

  • patients whose resected specimens were not examined histopathologically

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Jordan University Hospital

    Amman, Jubaiha, 13046

Other trials in Jordan

About this study

Official title: 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.

Being tested
Giemsa stain
Keywords
Histopathology, Sleeve gastrectomy, LSG, Gastritis, H. Pylori, Jordan, Middle East
Medical subject headings
Gastritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Giemsa stainOther

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

Study groups in NCT05101395
Study groupRoleWhat they receive
Patients with GastritisPatients who underwent sleeve gastrectomy and the histopathology result of resected gastric specimen showed the presence of gastritis in it.
Receives: Other: Giemsa stain

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

    Measured: start to end of the study, 5 years

Secondary outcomes (4)

  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)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: start to end of the study, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start1 Jan 2015
  3. Primary completion30 Oct 2019
  4. Study completion30 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
810 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101395
Sponsor's protocol ID
10/2020/8972
Status last verified
Oct 2021
First submitted
19 Oct 2021
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

    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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Gastritis H Pylori and Gastritis, run by University of Jordan at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of gastritis (time frame: start to end of the study, 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05101395, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.

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