Morbid ObesityNCT04967053
Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study.
An observational study of Morbid Obesity, run by Sohag University at 1 site in Egypt.
Trial summary
This study will be a retrospective study in which we will review patients who underwent laparoscopic sleeve gastrectomy at Sohag University Hospital in the period from january 2017 to May 2018.Assessment of outcomes as Effects on weight, Effects on co-morbidities and Post operative complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 20 May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: both males and females, age from 18 to 65 yrs complain of obesity with body mass index ≥ 40 kg/m2 or body mass index ≥ 35 kg/m2 with comorbidities diseases.
Who may be able to join
- age from 18 to 65 years old
- body mass index ≥ 35 kg/m2 with comorbidities disease or body mass index ≥ 40 kg/m2, with failure of non operative attempts to lose weight
- a minimum 2-year follow-up at our outpatient clinic.
Who cannot join
- secondary causes of obesity (e.g. endocrine diseases)
- patients unable to participate in medical follow-up;
- associated comorbidities or diseases impacting on weight loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study
This study will be a retrospective study in which we will review patients who underwent laparoscopic sleeve gastrectomy at Sohag University Hospital in the period from january 2017 to May 2018.Assessment of outcomes as Effects on weight, Effects on co-morbidities and Post operative complications.
- Conditions
- Morbid Obesity
- Being tested
- sleeve gastrectomy
- Keywords
- morbid obesity, sleeve gastrectomy, bariatric surgery, weight loss
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomyProcedure or surgery
Laparoscopic sleeve gastrectomy gives long-standing improvement or resolution of obesity-related conditions and also survival benefit. It is highly cost-effective. Surgical procedures for the treatment of obesity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on weight reported as percentage of excess weight loss
It is calculated as (initial weight - follow-up weight)/(initial weight - ideal weight corresponding to BMI 25) × 100%.
Measured: minimum 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jul 2021
- Primary completion20 May 2022
- Study completion20 May 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 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gadelkarim Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967053
- Sponsor's protocol ID
- Soh-med-21-07-13
- Status last verified
- May 2022
- First submitted
- 13 Jul 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: participant should be consented for data Sharing
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study
- ClinicalTrials.gov ID
- NCT04967053
- Acronym / sponsor ID
- Soh-med-21-07-13
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, sleeve gastrectomy, bariatric surgery, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 19 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.
This study will be a retrospective study in which we will review patients who underwent laparoscopic sleeve gastrectomy at Sohag University Hospital in the period from january 2017 to May 2018.Assessment of outcomes as Effects on weight, Effects on co-morbidities and Post operative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- both males and females, age from 18 to 65 yrs complain of obesity with body mass index ≥ 40 kg/m2 or body mass index ≥ 35 kg/m2 with comorbidities diseases.
Key inclusion criteria (3 listed)
- age from 18 to 65 years old
- body mass index ≥ 35 kg/m2 with comorbidities disease or body mass index ≥ 40 kg/m2, with failure of non operative attempts to lose weight
- a minimum 2-year follow-up at our outpatient clinic.
Key exclusion criteria (3 listed)
- secondary causes of obesity (e.g. endocrine diseases)
- patients unable to participate in medical follow-up;
- associated comorbidities or diseases impacting on weight loss.
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 |
|---|---|---|
| sleeve gastrectomyLaparoscopic sleeve gastrectomy gives long-standing improvement or resolution of obesity-related conditions and also survival benefit. It is highly cost-effective. Surgical procedures for the treatment of obesity. | Procedure or surgery | – |
Primary outcome
Effects on weight reported as percentage of excess weight loss
Time frame: minimum 2-year follow-up
It is calculated as (initial weight - follow-up weight)/(initial weight - ideal weight corresponding to BMI 25) × 100%.
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 1 Jun 2022.
- Individual participant dataSharing planned: Undecided. participant should be consented for data Sharing
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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 Morbid Obesity, 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 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 1 Jun 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?
Effects on weight reported as percentage of excess weight loss (time frame: minimum 2-year follow-up). 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 1 Jun 2022.