The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight LossNCT04765618
The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss
An observational study of The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss, run by Helwan University at 1 site in Egypt.
Trial summary
The incidence of Gall Stones after Bariatric surgery and its association with weight loss Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Dec 2018to 26 Dec 2020
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- (BMI) ≥35kg/m2 with one or more obesity-related comorbidities
- a BMI > 40 kg/m2 without coexisting medical problems
Who cannot join
- -a conrtaindication for bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of Gall Stones after Bariatric surgery and its association with weight loss
Read the detailed 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.
- Being tested
- bariatric surgery
- Keywords
- gall stones, ,bariatric surgery
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
laparoscopic sleeve gastrectomy,or gastric bypass
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Gall Stones after Bariatric surgery
Measured: the period between December 2018 and December 2019
Secondary outcomes (1)
effect of weight loss on Gall Stones formation after Bariatric surgery
effect of excess weight loss on gall stones formation after bariatric surgery
Measured: the period between December 2018 and December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start26 Dec 2018
- Primary completion26 Dec 2019
- Study completion26 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud alazawy, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765618
- Sponsor's protocol ID
- Helwan university
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
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.
PubMed 31858245Neuberg 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.
PubMed 317606073.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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss
- ClinicalTrials.gov ID
- NCT04765618
- Acronym / sponsor ID
- Helwan university
- Keywords
- gall stones, ,bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2020 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of Gall Stones after Bariatric surgery and its association with weight loss
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- (BMI) ≥35kg/m2 with one or more obesity-related comorbidities
- a BMI > 40 kg/m2 without coexisting medical problems
Key exclusion criteria (1 listed)
- -a conrtaindication for bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgerylaparoscopic sleeve gastrectomy,or gastric bypass | Procedure or surgery | – |
Primary outcome
The incidence of Gall Stones after Bariatric surgery
Time frame: the period between December 2018 and December 2019
1 secondary outcome
effect of weight loss on Gall Stones formation after Bariatric surgery
Time frame: the period between December 2018 and December 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 31858245Talha 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.
- Background: PubMed 31760607Neuberg 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.
- Background3.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.
- Individual participant dataSharing planned: Undecided. Undecided: It is not yet known if there will be a plan to make IPD available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss, run by Helwan University at 1 site in Egypt.
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 21 Feb 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 Egypt. 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?
The incidence of Gall Stones after Bariatric surgery (time frame: the period between December 2018 and December 2019). 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 NCT04765618, which also lists 3 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 21 Feb 2021.