Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

Laparoscopic Gastric Plication for Treatment of Morbid Obesity

Patrocinadores

Patrocinador principal: Bikkur Holim Hospital

Fuente Bikkur Holim Hospital
Resumen breve

The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. The patients will be followed during the time for 6 month, 1 year, two years and 5 years.

Descripción detallada

The patients will be selected with BMI more than 40, the operation will be primary between 18 to 60 years old. The patients will be informed about the procedure and different options. The patients will be in admission board for two or three days and any event will be recorded. the follow up will be recorded by the nurse, the surgeon and the dietitian, laboratory parameter includes CBC, T4,T3, TSH, ferrum, transferrin, ferritin, vit. B12, SMA, lipids, The end point will be the EBW achieved and events occurred.

Estado general Unknown status
Fecha de inicio March 2011
Fecha de Terminación March 2012
Fecha de finalización primaria March 2012
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Body Mass index loss 6mont.
Resultado secundario
Medida Periodo de tiempo
Complications Quality of life 6 month
Inscripción 200
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Laparoscopy surgery for morbid obesity

Descripción: The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/

Elegibilidad

Criterios:

Inclusion Criteria:

- BMI 40 or more

- Age between 18-60 years old

- ASA score 1-2

Exclusion Criteria:

- BMI less than 40

- Severe illness

- Psychiatric disorders

Género: All

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel
Sergio g Susmallian, dr Principal Investigator
Contacto general

Apellido: Sergio G Susmallian, dr

Teléfono: +972524637743

Email: [email protected]

Ubicación
Instalaciones: Bikur Holim Hospital
Ubicacion Paises

Israel

Fecha de verificación

February 2011

Fiesta responsable

Nombre Titulo: Sergio Susmallian

Organización: Bikkur Holim Hospital

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: LGP

Tipo: Other

Descripción: Patient underwent surgery for morbid obesity treatment between 18 to 60 years, and BMI of 40 ore more will divided in two groups, one hundred will be schedule for laparoscopic gastric plication. Our theory for this arm is that the procedure can offer the same results than the second arm with less cost and safety, reversibility included.

Etiqueta: LSG

Tipo: Other

Descripción: The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study.

Acrónimo LGP
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Single (Outcomes Assessor)

Fuente: ClinicalTrials.gov