Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass

Medico Economic Evaluation of a Temporary (6 Months) Intra-gastric Balloon in Morbidly Obese Patients Before a Gastric By-pass. A Randomised Multicenter Study Comparing the Usual Strategy to Two Types of Gastric Balloon

Patrocinadores

Patrocinador principal: Assistance Publique - Hôpitaux de Paris

Fuente Assistance Publique - Hôpitaux de Paris
Resumen breve

To demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (BMI > 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.

Descripción detallada

On inclusion, comorbidities associated with obesity will be recorded. After recording of the informed consent patients will be randomized in two groups: usual care or intra-gastric balloon. In the latter, a second randomization will be performed between air-filled balloon or water-filled balloon. Six months later, after withdrawal of the balloon (if required), laparoscopic gastric by-pass will be performed. Thereafter, patients will be followed during 6 months.

On each visit, inclusion, 3 months, 6 months, surgery, 1 month and 6 months post surgery, a medical and biological evaluation will be systematically performed.

The main criteria of judgement is the rate of admission in ICU during more than 24 hrs during the 30 days following surgery.

The secondary criteria of judgement is: the differences in pre-operative weight loss between the 2 groups, number of complications occurring during the 30 days after surgery, differences in different scales of quality of life (SF36, IWQOL-lite), differences in operative time, length of hospital stay, readmissions, and medical cots between the two strategies. Efficacy and tolerance of each type of balloon (air-filled or water-filled) will be compared in the intra-gastric balloon group.

Estado general Completed
Fecha de inicio October 2007
Fecha de Terminación July 2011
Fecha de finalización primaria July 2011
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Rate of admission in Intensive Care Units > 24 hrs during the 30-day period following gastric by-pass
Resultado secundario
Medida Periodo de tiempo
Differences in absolute weight loss at 6 months, before gastric by-pass, between the 2 strategies
Number and types of complications occurring during the 30-day post-operative period
Number of comorbidities present after the 6-month initial period
Differences in quality of life at the end of first 6-month period and at the end of the study
Differences in time of surgery, length of stay, readmission during the 30-day post by-pass period
Differences in medical costs between the 2 strategies 6 months before and after gastric by-pass
Inscripción 314
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: inflatable intra-gastric balloon

Descripción: inflatable intra-gastric balloon

Etiqueta de grupo de brazo: Intra-gastric balloon

Elegibilidad

Criterios:

Inclusion Criteria:

- Age between 18 and 75 years

- Patients with morbid obesity with BMI > 45 kg/m² requiring a gastric by-pass by laparoscopy.

- No efficacy of previous treatment on obesity

- Firmed informed consent

Exclusion Criteria:

- Patients in whom laparoscopy is contra-indicated

- Indication of gastric by-pass by laparoscopy retained without multidisciplinary advice

- Morbid obesity present since less than 5 years

- Severe associated pathology, non-related to obesity, impairing vital prognosis on a short or mean time

- Past history of gastric surgery, or gastric complication related to gastric lap-band

- Lack of health insurance

- Patient refusing to be followed 6 months before and after surgery

- Drug abuse

- Pregnancy or foreseeable pregnancy during the study

- Patients taking anticoagulant agents or steroids

- Patients with hiatal hernia > 4 cm

- Patients with active ulcerated esophagitis (grade C-D in Los Angeles Classification)

- Patients with duodenal or gastric ulcer

- Patients with gastric or esophageal varices

- Patients with NSAIDs not taking PPI

- Patients with bulimia

Género: All

Edad mínima: 18 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Benoit Coffin, PU-PH Principal Investigator Assistance Publique - Hôpitaux de Paris
Ubicación
Instalaciones: Hopital Louis Mourier
Ubicacion Paises

France

Fecha de verificación

October 2008

Fiesta responsable

Tipo: Sponsor

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

Etiqueta: Intra-gastric balloon

Tipo: Experimental

Descripción: Patients will receive either an air-filled or water-filled intra-gastric balloon.

Etiqueta: Usual care

Tipo: No Intervention

Descripción: Usual care will be given to the patients.

Acrónimo BIGPOM
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov