- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01583790
Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients
A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In the period 2006-2012 the ICBS-Israeli Center for Bariatric Surgery in Assuta Hospital has performed about 1500 bariatric surgeries including Laparoscopic Adjustable Gastric Banding, Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux en Y Gastric Bypass, and Duodenal switch. In addition, Pose and BPD procedures were performed.The ICBS team is comprised of a team of expert senior professionals in the obesity field, made up of the best bariatric surgeons, an expert endocrinologist who specializes in obesity and diabetes, a team of senior nutritionists and a supportive psychology team. During that period patients data were collected as part of the medical practice in the Center and included BMI, co-morbidities, weight loss programs the patients were involved in, pervious bariatric surgery and quality of life. During the entire 6 years of follow up data were collected which included weight loss, resolution of co-morbidity, changes in quality of life etc combined with training for healthy lifestyle.
The purpose of this retrospective study is to evaluate the key factors for surgery success that includes over 50% of original weight loss, resolution of co-morbidities. Factors that could affect surgical outcome such as age, repeated surgery, early side effects such as bleeding, leakage, thrombosis and lung emboli were recorded as well as later side effects such as herniation of the surgical area, production of gallbladder stones, vitamine deficiency and requirement of a revision surgery.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Tel Aviv, Israel
- Reclutamiento
- Assuta Medical Center
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Contacto:
- Asnat Raziel, MD
- Número de teléfono: 972-3-7645444
- Correo electrónico: drraziel@zahav.net.il
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Investigador principal:
- Asnat Raziel, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- patients meeting established criteria set by the National Institutes of Health (NIH) for candidacy for bariatric surgery
- patients having a body mass index (BMI) of 35 with co-morbid conditions or BMI larger or equal 40 with or without co-morbid conditions,
- patients having a comorbidity that should be improved by the surgery
- Patients that are able to comprehend the risks and benefits and the surgical procedure
- patients having no glandular etiology for their obesity
- patients that have attempted to lose weight by conventional means
- patients that are willing to be observed over a long period of time
Exclusion Criteria:
- patients that can not obey one of the inclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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no group
laparoscopic sleeve gastrectomy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Weightloss of patients
Periodo de tiempo: At least one year
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At least one year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Improvement of co-morbidities after surgery
Periodo de tiempo: At least one year
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Follow up visits were done at 1, 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery.
They included physical examinations, blood analysis and assessment of comorbidities in collaboration with attending family physician.
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At least one year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Asnat Raziel, MD, Medical Director, ICBS-Israeli Center for Bariatric Surgery
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AR-001-12
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