Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity

Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial

Patrocinadores

Patrocinador principal: Göteborg University

Colaborador: Helse Sor-Ost

Fuente Göteborg University
Resumen breve

The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index [BMI] > 50 kg/m2).

Descripción detallada

Surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. There are few studies comparing different surgical techniques, especially in a randomized setting.

Superobesity (BMI > 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. Laparoscopic techniques have been established to perform Roux-en-Y Gastric bypass and Biliopancreatic Diversion with Duodenal Switch which both are good options for treating superobesity.

This study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). Patients will be randomized to either surgical procedure and will be followed for five years.

Estado general Unknown status
Fecha de inicio April 2006
Fecha de Terminación December 2017
Fecha de finalización primaria December 2017
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
BMI 5 y
Metabolic normalization 5y
Gastro-intestinal side effects 5y
Resultado secundario
Medida Periodo de tiempo
Health economics 5y
Vitamin/mineral deficiencies 5y
Body composition 5y
Quality of life 5y
Eating pattern 5y
Inscripción 60
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Laparoscopic Biliopancreatic diversion with Duodenal switch

Etiqueta de grupo de brazo: 1

Tipo de intervención: Procedure

Nombre de intervención: Laparoscopic Roux-en-Y Gastric Bypass

Etiqueta de grupo de brazo: 2

Elegibilidad

Criterios:

Inclusion Criteria:

- BMI 50-60 kg/m2

Exclusion Criteria:

- Prior obesity operation

- Prior major abdominal surgical procedure

- Severe disabling cardiopulmonary disease

- Malignancy

- Oral steroid treatment

- Condition associated with poor compliance

Género: All

Edad mínima: 20 Years

Edad máxima: 50 Years

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
Dept of Surgery, Aker University Hospital | Oslo, Norway
Dept of Surgery, Sahlgrenska University Hospital | Gothenburg, 41345, Sweden
Ubicacion Paises

Norway

Sweden

Fecha de verificación

February 2017

Fiesta responsable

Tipo: Sponsor

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

Etiqueta: 1

Tipo: Experimental

Descripción: Laparoscopic Biliopancreatic diversion with Duodenal switch

Etiqueta: 2

Tipo: Active Comparator

Descripción: Laparoscopic Roux-en-Y Gastric Bypass

Acrónimo ASGARD
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov