Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04765618
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-19', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of Gall Stones after Bariatric surgery', 'timeFrame': 'the period between December 2018 and December 2019'}], 'secondaryOutcomes': [{'measure': 'effect of weight loss on Gall Stones formation after Bariatric surgery', 'timeFrame': 'the period between December 2018 and December 2019', 'description': 'effect of excess weight loss on gall stones formation after bariatric surgery'}]}, 'conditionsModule': {'keywords': ['gall stones', ',bariatric surgery'], 'conditions': ['The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss']}, 'referencesModule': {'references': [{'pmid': '31858245', 'type': 'BACKGROUND', 'citation': 'Talha A, Abdelbaki T, Farouk A, Hasouna E, Azzam E, Shehata G. Cholelithiasis after bariatric surgery, incidence, and prophylaxis: randomized controlled trial. Surg Endosc. 2020 Dec;34(12):5331-5337. doi: 10.1007/s00464-019-07323-7. Epub 2019 Dec 19.'}, {'pmid': '31760607', 'type': 'BACKGROUND', 'citation': 'Neuberg M, Blanchet MC, Gignoux B, Frering V. Long-Term Outcomes After One-Anastomosis Gastric Bypass (OAGB) in Morbidly Obese Patients. Obes Surg. 2020 Apr;30(4):1379-1384. doi: 10.1007/s11695-019-04287-4.'}, {'type': 'BACKGROUND', 'citation': '3.Vural A, Goksu K, Kahraman AN et al. Increased gallstone formation after sleeve gastrectomy and the preventive role of ursodeoxycholic acid. Acta Gastroenterol Belg. 2020;83(1):33-38. 4. MAGOULIOTIS D.E., TASIOPOULOU V.S., SVOKOS A.A. et al.Ursodeoxycholic acid in the prevention of gall stone formation after bariatric surgery : A meta-analysis. Obese Sur., 2008, 27 : 3021-3030 5.MANATSATHIT W., LEELASINJAROEN P., AL-HAMID H., et al. The incidence of cholelithiasis after sleeve gastrectomy and its association with weight loss. A two-centre retrospective cohort study. Int Jpatients submitted to sleeve gastrectomy compared to normal subjects. Obes Surg., 2009, 19 : 1515-1521. 6. MELISSAS J., KOUKOURAKI S., ASKOXYLAKIS J., et al. Sleeve gastrectomy - Arestrictive procedure? Obes Surg., 2007, 17 : 57-62 7. LI V.K.M., PULIDO N., MARTINEZ-SUARTEZ P.et al. Symptomatic gallstones after sleeve gastrectomy. Surg Endosc., 2009, 23 : 2488-92. 8. Altieri, M. S., Yang, J., Nie, L., Docimo, S et al. Incidence of cholecystectomy after bariatric surgery. Surgery for Obesity and Related Diseases, (2018). 14(7), 992-996. 9. Morais M, Faria G, Preto J, et al. Gallstones and bariatric surgery: to treat or not to treat? World J Surg. 2016;40(12):2904-10. 10.Guzmán HM, Sepúlveda M, Rosso N. et al .Incidence and Risk Factors for Cholelithiasis After Bariatric Surgery [published correction appears in Obes Surg. 2019 May 28;:]. Obes Surg. 2019;29(7):2110-2114. doi:10.1007/s11695-019-03760-4. 11. Sioka E, Zacharoulis D, Zachari E et al. Complicated gallstones after laparoscopic sleeve gastrectomy. J Obes, 2014. 468203.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of Gall Stones after Bariatric surgery and its association with weight loss', 'detailedDescription': 'Gallstone (GS) formation is common in obese patients, particularly during rapid weight loss.This study aimed to determine the incidence of GS in patients underwent bariatric surgery (BS) and the influence of weight loss on GS formation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Methods This was a prospective study conducted in Helwan University Hospitals in Egypt including 148 consecutive patients underwent BS during the period between December 2018 and December 2019. Patients with preoperative negative abdominal ultrasound(US) for GS were followed-up for at least 12 months.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (BMI) ≥35kg/m2 with one or more obesity-related comorbidities\n* a BMI \\> 40 kg/m2 without coexisting medical problems\n\nExclusion Criteria:\n\n-a conrtaindication for bariatric surgery'}, 'identificationModule': {'nctId': 'NCT04765618', 'briefTitle': 'The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss', 'orgStudyIdInfo': {'id': 'Helwan university'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bariatric surgery', 'type': 'PROCEDURE', 'description': 'laparoscopic sleeve gastrectomy,or gastric bypass'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helwan', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Dr.hossam hoseiny', 'geoPoint': {'lat': 29.84144, 'lon': 31.30084}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided: It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'general surgery assistant lecturer', 'investigatorFullName': 'Mahmoud alazawy', 'investigatorAffiliation': 'Helwan University'}}}}