Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study

Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study

Patrocinadores

Patrocinador principal: Oslo University Hospital

Colaborador: The Hospital of Vestfold

Fuente Oslo University Hospital
Resumen breve

The main study objective:

To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).

The main study hypothesis:

Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.

Descripción detallada

Technical data will later be published in detail

Estado general Active, not recruiting
Fecha de inicio February 2011
Fecha de Terminación May 2025
Fecha de finalización primaria May 2015
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Primary outcome: weight loss 2 years postoperatively
Resultado secundario
Medida Periodo de tiempo
Secondary outcome: Quality of life 2 years postoperative
Adverse events 2 years postoperative
Number of patients with vitamin deficiencies 2 years postoperative
Number of patients with mineral deficiencies 2 years postoperative
Number of participants with malnutrition 2 years postoperative
Weight loss 5 year 5 year postoperative
Health related Quality of life 5 years postoperative
Number of patients with malnutrition 5 years postoperative
Number of patients with mineral deficiencies 5 years postoperative
Number of patients with vitamin deficiencies 5 years postoperative
Adverse events 5 years
Weight loss 10 years 10 years postoperative
Adverse events 10 years postoperative
Number of patients with malnutrition 10 years postoperative
Number of patients with mineral deficiencies 10 years postoperative
Number of patients with vitamin deficiencies 10 years postoperative
Health related Quality of life 10 years postoperative
Inscripción 115
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: long-limb gastric bypass

Descripción: Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)

Etiqueta de grupo de brazo: long-limb bypass

Tipo de intervención: Procedure

Nombre de intervención: distal gastric bypass

Descripción: Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Etiqueta de grupo de brazo: Distal gastric bypass

Elegibilidad

Criterios:

Inclusion Criteria:

- BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery

- BMI 48 - 62 kg/m2 at study inclusion

- informed consent

- scheduled for bariatric surgery

Exclusion Criteria:

- previous bariatric surgery

- previous major abdominal surgery

- previous history or established urolithiasis

- viral hepatitis, liver cirrhosis of any kind

- factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)

Género: All

Edad mínima: 20 Years

Edad máxima: 60 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Tom Mala MD, PhD Rune Sandbu, MD, PhD Study Chair Aker University Hospital / The Hospital of Vestfold
Ubicación
Instalaciones: Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Ubicacion Paises

Norway

Fecha de verificación

January 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Oslo University Hospital

Nombre completo del investigador: Tom Mala

Título del investigador: Principal investigator Surgeon phd Tom Mala Rune Sandbu

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

Etiqueta: long-limb bypass

Tipo: Active Comparator

Descripción: Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)

Etiqueta: Distal gastric bypass

Tipo: Active Comparator

Descripción: Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Outcomes Assessor)

Fuente: ClinicalTrials.gov