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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Banded Group | Active Comparator | Placement of a 1.5 x 5.5 cm polypropylene band |
|
| Non-Banded Group | Placebo Comparator | Standard laparoscopic sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Band | Procedure | Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Weight Loss (TWL) | Total Weight Loss between the 2 groups (in kilograms) | Measured at 6, 12, 24 and 36 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of associated medical problems | Improvement 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Ashour, Ph.D. (Professor) | The surgical department of Medical Research Institute Hospital, Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The surgical department of Medical Research Institute Hospital, Alexandria University | Alexandria | 21531 | Egypt |
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
whole study period
Ask contact person
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| ID | Term |
|---|---|
| D002871 | Chromosome Banding |
| D027963 | Chloride-Bicarbonate Antiporters |
| ID | Term |
|---|---|
| D020732 | Cytogenetic Analysis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Non-Band | Procedure | Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure |
|
| 6, 12, 24, and 36 months. |
| Resolution of associated medical problems | Improvement 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. | 6, 12, 24, and 36 months. |
| Resolution of associated medical problems | Improvement 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). | 6, 12, 24, and 36 months. |
| Resolution of associated medical problems | Improvement 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. | 6, 12, 24, and 36 months. |
| Complications | Postoperative complications classified by the Clavien-Dindo system. | post operative, 12, 24, and 36 months |
| Food Intolerance | Measured through patient-reported outcomes using the validated food intolerance questionnaire by Suter et al. | 12, 24, and 36 months |
| Volumetric Analysis | Evaluation of the gastric pouch volume postoperatively using radiographic imaging or endoscopic techniques | 12, 24, and 36 months |
| Quality of Life (QOL) | Assessed using validated questionnaires such as the SF-36 | 6, 12, 24, and 36 months |
| BODY-Q | Assessed using validated questionnaires | 12, 24, and 36 months |
| D003933 | Diagnosis |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D017920 | Antiporters |
| D016623 | Ion Pumps |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D064606 | SLC4A Proteins |
| D000070590 | Solute Carrier Proteins |
| D008562 | Membrane Glycoproteins |
| D008565 | Membrane Proteins |