Obesity, MorbidNCT06298942
Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy
A study testing natural band and silicone band in people with Obesity, Morbid, run by Minia University at 1 site in Egypt.
Trial summary
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- natural band and silicone band
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 15 Nov 2025
- 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 65
- 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
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)
Read the detailed description
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost
- Conditions
- Obesity, Morbid
- Being tested
- natural band, silicone band
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural bandProcedure or surgery
to use the round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
silicone bandProcedure or surgery
to use synesthetic band with sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| natural band | Experimental | to use an round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy Receives: Procedure: natural band |
| silicone band | Active comparator | to use a synesthetic band with sleeve gastrectomy Receives: Procedure: silicone band |
What is being measured
The primary outcome is the main question the study is designed to answer.
total cost
total operative cost in Egyptian pound (LE)
Measured: 12 hours
food intolerance
food intolerance at one year food tolerance arabic score questionnaire
Measured: 1 year
Secondary outcomes (3)
%EWL
percentage of weight loss at one year measured as (initial weight - follow-up weight) / (initial weight - bodyweight at a BMI of 25 kg/ m2) x 100
Measured: 1 year
complications rate
the incidence of early and late complications according to Clavien-Dindo (CD)
Measured: 1 year
improvement of comorbidities
the incidence of improvement of comorbidities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Mar 2024
- Primary completion15 Oct 2025
- Study completion15 Nov 2025
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
- None (open label)
- Enrolment
- 250 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
- NCT06298942
- Sponsor's protocol ID
- fac.med.24.9
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2024
- Last updated
- 19 Oct 2026
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06298942
- Acronym / sponsor ID
- fac.med.24.9
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 7 Mar 2024 (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 compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)
Detailed description
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natural band | Experimental | Procedure: natural bandto use an round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy |
| silicone band | Active comparator | Procedure: silicone bandto use a synesthetic band with sleeve gastrectomy |
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 65
- 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 |
|---|---|---|
| natural bandto use the round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy | Procedure or surgery | natural band |
| silicone bandto use synesthetic band with sleeve gastrectomy | Procedure or surgery | silicone band |
Primary outcome
total cost
Time frame: 12 hours
total operative cost in Egyptian pound (LE)
food intolerance
Time frame: 1 year
food intolerance at one year food tolerance arabic score questionnaire
3 secondary outcomes
%EWL
Time frame: 1 year
complications rate
Time frame: 1 year
improvement of comorbidities
Time frame: 1 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 19 Oct 2026.
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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 natural band and silicone band 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 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 19 Oct 2026. 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?
total cost (time frame: 12 hours). 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 19 Oct 2026.