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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04765618
Other study ID # Helwan university
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 26, 2018
Est. completion date December 26, 2020

Study information

Verified date February 2021
Source Helwan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The incidence of Gall Stones after Bariatric surgery and its association with weight loss


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date December 26, 2020
Est. primary completion date December 26, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - (BMI) =35kg/m2 with one or more obesity-related comorbidities - a BMI > 40 kg/m2 without coexisting medical problems Exclusion Criteria: -a conrtaindication for bariatric surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
bariatric surgery
laparoscopic sleeve gastrectomy,or gastric bypass

Locations

Country Name City State
Egypt Dr.hossam hoseiny Helwan Cairo

Sponsors (1)

Lead Sponsor Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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.

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of Gall Stones after Bariatric surgery the period between December 2018 and December 2019
Secondary effect of weight loss on Gall Stones formation after Bariatric surgery effect of excess weight loss on gall stones formation after bariatric surgery the period between December 2018 and December 2019