CholelithiasisNCT05803668
Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital
An observational study of Cholelithiasis, run by Sohag University at 1 site in Egypt.
Trial summary
To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholelithiasis
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 28 Feb 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients underwent Bariatric Surgery
Who may be able to join
- All adult patients underwent bariatric surgery with minimum postoperative follow up period of one year duration will be included in the study.
Who cannot join
- Patients who had cholecystectomy during the bariatric surgery.
- Pediatric age.
Trial locations and contacts
1 site in 1 country.
About this study
To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.
Read the detailed description
To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.
A retrospective study with prospective collective data will be conducted including all patients underwent bariatric surgery in general surgical department, Sohag University between January 2015 and December 2022 who did not have gallstones in the preoperative abdominal ultrasound examinations.
Medical records will be reviewed. Demographic data such as age, gender, BMI, comorbidities as ( DM, hypertension and hyperlipidemia ) and time elapsed between the surgery to post-surgery US examination. The findings of the US examinations will be collected and analyzed. Data will be analyzed to obtain descriptive and inferential statistics.
- Conditions
- Cholelithiasis
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who developed gall stones | Not described | |
| patients who did not develope gall stones | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who develop gall bladder stones after bariatric surgery
Evalution of gall bladder stone formation postoperaive and its relation with comorbidities
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803668
- Sponsor's protocol ID
- soh-Med-23-03-06MS
- Status last verified
- Jul 2023
- First submitted
- 27 Mar 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05803668
- Acronym / sponsor ID
- soh-Med-23-03-06MS
- Conditions
- Cholelithiasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 7 Apr 2023 (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.
To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.
Detailed description
To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.
A retrospective study with prospective collective data will be conducted including all patients underwent bariatric surgery in general surgical department, Sohag University between January 2015 and December 2022 who did not have gallstones in the preoperative abdominal ultrasound examinations.
Medical records will be reviewed. Demographic data such as age, gender, BMI, comorbidities as ( DM, hypertension and hyperlipidemia ) and time elapsed between the surgery to post-surgery US examination. The findings of the US examinations will be collected and analyzed. Data will be analyzed to obtain descriptive and inferential statistics.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who developed gall stones | – | – |
| patients who did not develope gall stones | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients underwent Bariatric Surgery
Key inclusion criteria (1 listed)
- All adult patients underwent bariatric surgery with minimum postoperative follow up period of one year duration will be included in the study.
Key exclusion criteria (2 listed)
- Patients who had cholecystectomy during the bariatric surgery.
- Pediatric age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who develop gall bladder stones after bariatric surgery
Time frame: one year
Evalution of gall bladder stone formation postoperaive and its relation with comorbidities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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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 Cholelithiasis, run by Sohag 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. 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?
Results are not available in the source record.
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?
Number of patients who develop gall bladder stones after bariatric surgery (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2023.