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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
219
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, Egypt
Total Weight Loss (TWL)
Total Weight Loss between the 2 groups (in kilograms)
Time frame: Measured at 6, 12, 24 and 36 months postoperatively
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 6, 12, 24, and 36 months.
Complications
Postoperative complications classified by the Clavien-Dindo system.
Time frame: post operative, 12, 24, and 36 months
Food Intolerance
Measured through patient-reported outcomes using the validated food intolerance questionnaire by Suter et al.
Time frame: 12, 24, and 36 months
Volumetric Analysis
Evaluation of the gastric pouch volume postoperatively using radiographic imaging or endoscopic techniques
Time frame: 12, 24, and 36 months
Quality of Life (QOL)
Assessed using validated questionnaires such as the SF-36
Time frame: 6, 12, 24, and 36 months
BODY-Q
Assessed using validated questionnaires
Time frame: 12, 24, and 36 months
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