Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05101395
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-11-04', 'releaseDate': '2022-04-05'}], 'estimatedResultsFirstSubmitDate': '2022-04-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005756', 'term': 'Gastritis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001399', 'term': 'Azure Stains'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 810}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-30', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of gastritis', 'timeFrame': 'start to end of the study, 5 years', 'description': 'proportion of patients who underwent sleeve gastrectomy who have gastritis in their resected gastric specimen at or during study period.\n\ncalculated as (number of pt with gastritis / number of examined resected gastric specimens)'}, {'measure': 'Prevalence of H.pylori gastritis', 'timeFrame': 'start to end of the study, 5 years', 'description': 'proportion of patients who underwent sleeve gastrectomy who have H.pylori related gastritis in their resected gastric specimen at or during study period.\n\ncalculated as (number of pt with H.pylori gastritis / number of examined resected gastric specimens)'}], 'secondaryOutcomes': [{'measure': 'Prevalence of other histopathological findings', 'timeFrame': 'start to end of the study, 5 years', 'description': '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.\n\ncalculated as (number of pt with the histopathological finding / number of examined resected gastric specimens)'}, {'measure': 'likelihood ratio between H.pylori gastritis and advancing age', 'timeFrame': 'start to end of the study, 5 years', 'description': '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.'}, {'measure': 'likelihood ratio between H.pylori gastritis and female gender', 'timeFrame': 'start to end of the study, 5 years', 'description': '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.'}, {'measure': 'likelihood ratio between H.pylori gastritis and BMI', 'timeFrame': 'start to end of the study, 5 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Histopathology', 'Sleeve gastrectomy', 'LSG', 'Gastritis', 'H. Pylori', 'Jordan', 'Middle East'], 'conditions': ['Gastritis H Pylori', 'Gastritis', 'Obesity Associated Disorder']}, 'referencesModule': {'references': [{'pmid': '31619643', 'type': 'BACKGROUND', 'citation': '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': '30771070', 'type': 'BACKGROUND', 'citation': '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': '22248433', 'type': 'BACKGROUND', 'citation': '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': '24560848', 'type': 'BACKGROUND', 'citation': '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': '28063114', 'type': 'BACKGROUND', 'citation': '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': '29151240', 'type': 'BACKGROUND', 'citation': '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': '27020497', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '21945699', 'type': 'BACKGROUND', 'citation': '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': '31704426', 'type': 'BACKGROUND', 'citation': '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': '23338049', 'type': 'BACKGROUND', 'citation': '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': '25835983', 'type': 'BACKGROUND', 'citation': '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': '28405878', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '31384574', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Obese patients who undergo sleeve gastrectomy for bariatric reasons', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent sleeve gastrectomy\n* surgery was performed between January 2015 and October 2019\n\nExclusion Criteria:\n\n* patients whose resected specimens were not examined histopathologically'}, 'identificationModule': {'nctId': 'NCT05101395', 'briefTitle': 'Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens: A Cross-Sectional', 'orgStudyIdInfo': {'id': '10/2020/8972'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Gastritis', 'description': 'Patients who underwent sleeve gastrectomy and the histopathology result of resected gastric specimen showed the presence of gastritis in it.', 'interventionNames': ['Other: Giemsa stain']}], 'interventions': [{'name': 'Giemsa stain', 'type': 'OTHER', 'description': 'Giemsa special stain was employed for detection of H. Pylori microorganisms.', 'armGroupLabels': ['Patients with Gastritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13046', 'city': 'Amman', 'state': 'Jubaiha', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Raed Al-Taher, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jordan University Hospital'}, {'name': 'Mohammad Z Rashdan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan University Hospital'}, {'name': 'Firas I Obeidat, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Jordan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior General Surgery Resident', 'investigatorFullName': 'Hanan Ibrahim Mansour', 'investigatorAffiliation': 'University of Jordan'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-05', 'type': 'RELEASE'}, {'date': '2022-11-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hanan Ibrahim Mansour, Senior General Surgery Resident, University of Jordan'}}}}