Obesity, MorbidNCT05603338
Naturally Banded Sleeve Gastrectomy
A study testing LSG with omental band and LSG in people with Obesity, Morbid, run by Minia University at 1 site in Egypt.
Trial summary
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- LSG with omental band and LSG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 20 Feb 2024
- 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 60 years
- All sexes
- No healthy volunteers
- 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
- previous restrictive bariatric procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
Read the detailed description
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
- Conditions
- Obesity, Morbid
- Being tested
- LSG with omental band, LSG
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSG with omental bandProcedure or surgery
LSG with omental band
LSGProcedure or surgery
just to do sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| LSG | Active comparator | just laparoscopic sleeve gastrectomy without banding Receives: Procedure: LSG |
| LSG with omental band | Experimental | laparoscopic sleeve gastrectomy with omental banding Receives: Procedure: LSG with omental band |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect on 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
the size of gastric pouch at one year
the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study
Measured: 12 months
Secondary outcomes (3)
the effect on comorbidities
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
Measured: 12 monthts
operative time
operative time in minutes from skin incision to skin closure
Measured: 6 hours
the incidences of complications
the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy
Measured: 12 monthss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2022
- Primary completion30 Jan 2024
- Study completion20 Feb 2024
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 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
- NCT05603338
- Sponsor's protocol ID
- fac.med 22.33
- Status last verified
- Apr 2024
- First submitted
- 28 Oct 2022
- Last updated
- 12 Apr 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturally Banded Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05603338
- Acronym / sponsor ID
- fac.med 22.33
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 2 Nov 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.
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
Detailed description
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG | Active comparator | Procedure: LSGjust laparoscopic sleeve gastrectomy without banding |
| LSG with omental band | Experimental | Procedure: LSG with omental bandlaparoscopic sleeve gastrectomy with omental banding |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 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
- previous restrictive bariatric procedure
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| LSG with omental bandLSG with omental band | Procedure or surgery | LSG with omental band |
| LSGjust to do sleeve gastrectomy | Procedure or surgery | LSG |
Primary outcome
the effect on weight loss
Time frame: 12 months
the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
the size of gastric pouch at one year
Time frame: 12 months
the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study
3 secondary outcomes
the effect on comorbidities
Time frame: 12 monthts
operative time
Time frame: 6 hours
the incidences of complications
Time frame: 12 monthss
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 12 Apr 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 LSG with omental band and LSG in people with Obesity, Morbid, 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 4 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 12 Apr 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 weight loss (time frame: 12 months). The study lists 2 primary outcomes in all. 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 12 Apr 2024; AzTrials last refreshed its copy on 2 Nov 2026.