Morbid ObesityNCT04980417
Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone
A study testing concomitant cholecystectomy in people with Morbid Obesity and Gallstone, run by Minia University at 1 site in Egypt.
Trial summary
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Gallstone
- What is being tested?
- concomitant cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2021to 24 Jul 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 35
- presence of gallstone
- fit for laparoscopic surgery
Who cannot join
- BMI < 35
- unfit for surgery
- refuse to share in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concomitant Cholecystectomy With Bariatric Surgery Versus Delayed Post Bariatric Cholecystectomy for Obesity With Gallstone
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients
Read the detailed description
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients. patients will be divided into 2 group: group1, will be operated by the bariatric surgery and cholecystectomy in the same session. group 2 will be operated by cholecystectomy at least 6 months after bariatric surgery or whenever develop complications
- Conditions
- Morbid Obesity, Gallstone
- Being tested
- concomitant cholecystectomy
- Medical subject headings
- Obesity, Morbid, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concomitant cholecystectomyProcedure or surgery
Also called delayed cholecystectomy
delayed cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| concomitant cholecystectomy | Experimental | concomitant cholecystectomy with bariatric procedure Receives: Procedure: concomitant cholecystectomy |
| delayed cholecystectomy | Active comparator | delayed cholecystectomy Receives: Procedure: concomitant cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of complications
the incidence of complications of cholecystectomy or of left of gallstone
Measured: one year
Secondary outcomes (2)
operative time of cholecystectomy
operative time of cholecystectomy
Measured: 30-90 minutes
%EWL
percentage of excess weight loss
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 posted28 Jul 2021
- Study start21 Jul 2021
- Primary completion5 Jul 2022
- Study completion24 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Minia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980417
- Sponsor's protocol ID
- fac.med 21.32
- Status last verified
- Oct 2022
- First submitted
- 18 Jul 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Cholecystectomy With Bariatric Surgery Versus Delayed Post Bariatric Cholecystectomy for Obesity With Gallstone
- ClinicalTrials.gov ID
- NCT04980417
- Acronym / sponsor ID
- fac.med 21.32
- Conditions
- Morbid Obesity, Gallstone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 24 Jul 2022 (actual)
- First posted
- 28 Jul 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.
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients
Detailed description
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients. patients will be divided into 2 group: group1, will be operated by the bariatric surgery and cholecystectomy in the same session. group 2 will be operated by cholecystectomy at least 6 months after bariatric surgery or whenever develop complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concomitant cholecystectomy | Experimental | Procedure: concomitant cholecystectomyconcomitant cholecystectomy with bariatric procedure |
| delayed cholecystectomy | Active comparator | Procedure: concomitant cholecystectomydelayed cholecystectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 35
- presence of gallstone
- fit for laparoscopic surgery
Key exclusion criteria (3 listed)
- BMI < 35
- unfit for surgery
- refuse to share in the study
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 |
|---|---|---|
| concomitant cholecystectomyAlso: delayed cholecystectomydelayed cholecystectomy | Procedure or surgery | concomitant cholecystectomy, delayed cholecystectomy |
Primary outcome
the incidence of complications
Time frame: one year
the incidence of complications of cholecystectomy or of left of gallstone
2 secondary outcomes
operative time of cholecystectomy
Time frame: 30-90 minutes
%EWL
Time frame: one year
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 4 Oct 2022.
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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?
A study testing concomitant cholecystectomy in people with Morbid Obesity and Gallstone, run by Minia 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 3 inclusion and 3 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 4 Oct 2022. 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 complications (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 4 Oct 2022.