Morbid Obesity Requiring Bariatric SurgeryNCT07100327
Banded Versus Non-Banded Sleeve in Class IV Obese Patients
A study testing Band and Non-Band in people with Morbid Obesity Requiring Bariatric Surgery, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
Obesity remains a major global health challenge, with Class IV super obesity (BMI ≥ 50 kg/m²) being the most severe form. This condition is associated with numerous comorbidities including type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia, which significantly reduce life expectancy and quality… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity Requiring Bariatric Surgery
- What is being tested?
- Band and Non-Band
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 15 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years
- BMI ≥ 50 kg/m² (Class IV obesity)
- No prior gastrointestinal surgeries
- No significant psychiatric or medical contraindications to surgery
- Ability to provide informed consent
Who cannot join
- BMI < 50 kg/m²
- Refusal to undergo band placement
- Active reflux disease or PPI use
- Prior bariatric surgery
- Pregnancy plans during the study period
- Active cancer or life-limiting illness
Show all 9Show fewer
- Substance abuse or non-compliance with postoperative care
- Gastroesophageal reflux disease.
- Hiatal hernia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, 21531
About this study
Official title: Randomized Controlled Trial (RCT) of Banded Versus Non-Banded Sleeve Gastrectomy in Class IV Obese Patients: 3-Year Follow-up
Obesity remains a major global health challenge, with Class IV super obesity (BMI ≥ 50 kg/m²) being the most severe form. This condition is associated with numerous comorbidities including type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia, which significantly reduce life expectancy and quality of life. Bariatric surgery, particularly sleeve gastrectomy (SG), has been shown to be an effective treatment for morbid obesity. While SG results in significant weight loss and improvement of comorbidities, some patients experience weight regain over time.
Banded sleeve gastrectomy (BSG) has been proposed as a modification of SG to enhance long-term outcomes by providing additional restriction via a polypropylene band around the proximal gastric pouch. Although initial evidence for banded procedures suggests improved outcomes, particularly in the context of weight loss and reduced weight regain, specific evidence for Class IV obesity remains limited.
Read the detailed description
This study aims to evaluate the effectiveness of adding a band to sleeve gastrectomy in patients with Class IV obesity by comparing weight loss, comorbidity resolution, complications, and quality of life outcomes over a 3-year period.
- Being tested
- Band, Non-Band
- Keywords
- Class IV Obese Patients, Banded versus Non-Banded Sleeve Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BandProcedure or surgery
Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction.
Non-BandProcedure or surgery
Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure
| Study group | Role | What they receive |
|---|---|---|
| Banded Group | Active comparator | Placement of a 1.5 x 5.5 cm polypropylene band Receives: Procedure: Band |
| Non-Banded Group | Placebo comparator | Standard laparoscopic sleeve gastrectomy Receives: Procedure: Non-Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weight Loss (TWL)
Total Weight Loss between the 2 groups (in kilograms)
Measured: Measured at 6, 12, 24 and 36 months postoperatively
Secondary outcomes (9)
Change in associated medical problems
Change or resolution of conditions like type 2 diabetes. Your doctor or a healthcare professional will perform a simple blood test, which may involve a finger prick or drawing blood from your arm.
If a finger prick is used, you may get immediate results. If blood is sent to a lab, results are typically available within a day.
The HbA1c (Hemoglobin A1c) test is a blood test used to measure your average blood sugar (glucose) levels over the past two to three months, providing a long-term indicator of blood glucose control and helping to diagnose and monitor diabetes and prediabetes.
An HbA1c level below 5.7% is considered healthy. A result between 5.7% and 6.4% indicates prediabetes. A result of 6.5% or higher on two separate tests is used to diagnose diabetes. For individuals with diabetes, the HbA1c test helps monitor the effectiveness of diabetes management.
Measured: 6, 12, 24, and 36 months.
Change in associated medical problems
Change or resolution of conditions like hypertension. Blood pressure is measured in millimeters of mercury (mmHg) and is expressed as two numbers: systolic pressure (when the heart beats) over diastolic pressure (when the heart rests). A normal blood pressure reading is generally considered to be below 120/80 mmHg.
Normal Blood Pressure: Generally, a reading of 120/80 mmHg or lower is considered normal.
High Blood Pressure (Hypertension): Readings of 130/80 mmHg or higher are generally considered high.
Measured: 6, 12, 24, and 36 months.
Change in associated medical problems
Change or resolution of conditions like obstructive sleep apnea. Obstructive Sleep Apnea (OSA) severity is primarily measured using the Apnea-Hypopnea Index (AHI), which quantifies the number of breathing interruptions (apneas) and reduced airflow episodes (hypopneas) per hour of sleep. The AHI, determined through polysomnography (PSG), categorizes OSA as mild (AHI 5-14), moderate (AHI 15-30), or severe (AHI >30).
Measured: 6, 12, 24, and 36 months.
Change in associated medical problems
Change or resolution of conditions like hyperlipidemia. Hyperlipidemia, or high cholesterol, is measured through a lipid panel, a blood test that assesses various types of cholesterol and triglycerides, with results typically reported in milligrams per deciliter (mg/dL). This test usually requires a period of fasting beforehand, and a healthcare professional will draw a blood sample from a vein.
Measured: 6, 12, 24, and 36 months.
Complications
Postoperative complications classified by the Clavien-Dindo system.
Measured: post operative, 12, 24, and 36 months
Food Intolerance
Measured through patient-reported outcomes using the validated food intolerance questionnaire by Suter et al.
Measured: 12, 24, and 36 months
Volumetric Analysis
Evaluation of the gastric pouch volume postoperatively using radiographic imaging or endoscopic techniques
Measured: 12, 24, and 36 months
Quality of Life (QOL)
Assessed using validated questionnaires such as the SF-36 The SF-36 is a 36-item, patient-reported survey that measures health-related quality of life.
Purpose: Evaluates general physical and mental health status from a patient's point of view.
Time to complete: Takes about 5 to 10 minutes. Scoring range: Results are scored from 0 to 100, where 0 represents maximum disability and 100 represents no disability or optimal health.
Measured: 6, 12, 24, and 36 months
BODY-Q
Assessed using validated questionnaires The BODY-Q is a patient-reported outcome measure (PROM) designed to evaluate the physical, emotional, and social well-being of adults undergoing weight loss treatments, bariatric surgery, or body contouring.
Clinicians select specific subsets of scales relevant to their patient's treatment plan. Items use simple Likert-scale responses (such as "not at all bothered" to "extremely bothered"). Raw scores are transformed via Rasch measurement theory into linear interval scores ranging from 0 to 100, where higher scores generally reflect better appearance or higher quality of life.
Measured: 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 Jun 2022
- Primary completion15 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid Obesity Requiring Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- Model description
- * Banded Group: Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction. * Non-Banded Group: Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
- Investigators
- Mohamed Ashour, Ph.D. (Professor), Principal investigator, The surgical department of Medical Research Institute Hospital, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100327
- Sponsor's protocol ID
- RCT Banded vs Non in Class IV
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial (RCT) of Banded Versus Non-Banded Sleeve Gastrectomy in Class IV Obese Patients: 3-Year Follow-up
- ClinicalTrials.gov ID
- NCT07100327
- Acronym / sponsor ID
- RCT Banded vs Non in Class IV
- Keywords
- Class IV Obese Patients, Banded versus Non-Banded Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 3 Aug 2025 (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.
Obesity remains a major global health challenge, with Class IV super obesity (BMI ≥ 50 kg/m²) being the most severe form. This condition is associated with numerous comorbidities including type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia, which significantly reduce life expectancy and quality of life. Bariatric surgery, particularly sleeve gastrectomy (SG), has been shown to be an effective treatment for morbid obesity. While SG results in significant weight loss and improvement of comorbidities, some patients experience weight regain over time.
Banded sleeve gastrectomy (BSG) has been proposed as a modification of SG to enhance long-term outcomes by providing additional restriction via a polypropylene band around the proximal gastric pouch. Although initial evidence for banded procedures suggests improved outcomes, particularly in the context of weight loss and reduced weight regain, specific evidence for Class IV obesity remains limited.
Detailed description
This study aims to evaluate the effectiveness of adding a band to sleeve gastrectomy in patients with Class IV obesity by comparing weight loss, comorbidity resolution, complications, and quality of life outcomes over a 3-year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- * Banded Group: Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction. * Non-Banded Group: Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure.
| Arm | Type | Receives |
|---|---|---|
| Banded Group | Active comparator | Procedure: BandPlacement of a 1.5 x 5.5 cm polypropylene band |
| Non-Banded Group | Placebo comparator | Procedure: Non-BandStandard laparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-60 years
- BMI ≥ 50 kg/m² (Class IV obesity)
- No prior gastrointestinal surgeries
- No significant psychiatric or medical contraindications to surgery
- Ability to provide informed consent
Key exclusion criteria (9 listed)
- BMI < 50 kg/m²
- Refusal to undergo band placement
- Active reflux disease or PPI use
- Prior bariatric surgery
- Pregnancy plans during the study period
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 |
|---|---|---|
| BandLaparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction. | Procedure or surgery | Banded Group |
| Non-BandStandard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure | Procedure or surgery | Non-Banded Group |
Primary outcome
Total Weight Loss (TWL)
Time frame: Measured at 6, 12, 24 and 36 months postoperatively
Total Weight Loss between the 2 groups (in kilograms)
9 secondary outcomes
Change in associated medical problems
Time frame: 6, 12, 24, and 36 months.
Change in associated medical problems
Time frame: 6, 12, 24, and 36 months.
Change in associated medical problems
Time frame: 6, 12, 24, and 36 months.
Change in associated medical problems
Time frame: 6, 12, 24, and 36 months.
Complications
Time frame: post operative, 12, 24, and 36 months
Food Intolerance
Time frame: 12, 24, and 36 months
Volumetric Analysis
Time frame: 12, 24, and 36 months
Quality of Life (QOL)
Time frame: 6, 12, 24, and 36 months
BODY-Q
Time frame: 12, 24, and 36 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 11 Sep 2026.
- Individual participant dataSharing planned: Yes. The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person
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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.
Mohamed Ashour, Ph.D. (Professor) principal investigator
The surgical department of Medical Research Institute Hospital, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Band and Non-Band in people with Morbid Obesity Requiring Bariatric Surgery, run by General Committee of Teaching Hospitals and Institutes, Egypt 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 5 inclusion and 9 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 11 Sep 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. Some participants in this study may receive a placebo. 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 Weight Loss (TWL) (time frame: Measured at 6, 12, 24 and 36 months postoperatively). 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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.