Obesity, MorbidNCT05590208
Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
A study testing sleeve gastrectomy+ cruroplasty+ omental rap in people with Obesity, Morbid and GERD, run by Minia University at 1 site in Egypt.
Trial summary
in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, GERD
- What is being tested?
- sleeve gastrectomy+ cruroplasty+ omental rap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2022to 20 Dec 2023
- 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
- obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
Who cannot join
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 60
- patient with previous upper abdominal surgery either for obesity or other diseases
- revisional bariatric procedures
Trial locations and contacts
1 site in 1 country.
About this study
in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction
Read the detailed description
in this study the patients that have morbid obesity concomitant GERD will managed by sleeve gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around the gastroesophageal junction
- Conditions
- Obesity, Morbid, GERD
- Being tested
- sleeve gastrectomy+ cruroplasty+ omental rap
- Medical subject headings
- Obesity, Morbid, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomy+ cruroplasty+ omental rapProcedure or surgery
sleeve gastrectomy+ cruroplasty+ omental rap
| Study group | Role | What they receive |
|---|---|---|
| sleeve gastrectomy+ cruroplasty + omental rape | Experimental | sleeve gastrectomy+ cruroplasty + omental rape Receives: Procedure: sleeve gastrectomy+ cruroplasty+ omental rap |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect on GERD
change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire
Measured: 6 months
Secondary outcomes (2)
weight loss
the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
Measured: 12 months
comorbidities
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start12 Oct 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT05590208
- Sponsor's protocol ID
- fac.med 22.64
- Status last verified
- Dec 2022
- First submitted
- 1 Oct 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
- ClinicalTrials.gov ID
- NCT05590208
- Acronym / sponsor ID
- fac.med 22.64
- Conditions
- Obesity, Morbid, GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 21 Oct 2022 (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 the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction
Detailed description
in this study the patients that have morbid obesity concomitant GERD will managed by sleeve gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around the gastroesophageal junction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sleeve gastrectomy+ cruroplasty + omental rape | Experimental | Procedure: sleeve gastrectomy+ cruroplasty+ omental rapsleeve gastrectomy+ cruroplasty + omental rape |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
Key exclusion criteria (5 listed)
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 60
- patient with previous upper abdominal surgery either for obesity or other diseases
- revisional bariatric procedures
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 gastrectomy+ cruroplasty+ omental rapsleeve gastrectomy+ cruroplasty+ omental rap | Procedure or surgery | sleeve gastrectomy+ cruroplasty + omental rape |
Primary outcome
the effect on GERD
Time frame: 6 months
change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire
2 secondary outcomes
weight loss
Time frame: 12 months
comorbidities
Time frame: 12 months
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 17 Jan 2024.
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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 sleeve gastrectomy+ cruroplasty+ omental rap in people with Obesity, Morbid and GERD, 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 5 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 17 Jan 2024. 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 effect on GERD (time frame: 6 months). 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 17 Jan 2024.