Morbid Obesity Requiring Bariatric Surgery
Conditions
Keywords
Class IV Obese Patients, Banded versus Non-Banded Sleeve Gastrectomy
Brief 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 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.
Interventions
PROCEDUREBand
Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction.
PROCEDURENon-Band
Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure
Sponsors
General Committee of Teaching Hospitals and Institutes, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Substance abuse or non-compliance with postoperative care * Gastroesophageal reflux disease. * Hiatal hernia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Weight Loss (TWL) | Measured at 6, 12, 24 and 36 months postoperatively | Total Weight Loss between the 2 groups (in kilograms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in associated medical problems | 6, 12, 24, and 36 months. | 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. |
| Complications | post operative, 12, 24, and 36 months | Postoperative complications classified by the Clavien-Dindo system. |
| Food Intolerance | 12, 24, and 36 months | Measured through patient-reported outcomes using the validated food intolerance questionnaire by Suter et al. |
| Volumetric Analysis | 12, 24, and 36 months | Evaluation of the gastric pouch volume postoperatively using radiographic imaging or endoscopic techniques |
| Quality of Life (QOL) | 6, 12, 24, and 36 months | 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. |
| BODY-Q | 12, 24, and 36 months | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed Ashour, Ph.D. (Professor)
The surgical department of Medical Research Institute Hospital, Alexandria University
Outcome results
None listed