Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
A prospective randomized clinical trial of patients undergoing bariatric surgery.
Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.
Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients with body mass index (BMI) >40 Kg/m2 or BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.
Exclusion Criteria:
- all kind of previous breast surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PENS with training
Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
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The participants underwent one 30-min session every week for 12 consecutive weeks.
PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm.
PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain.
PENS was delivered simultaneously in both pectoral muscles.
Patients underwent specific training exercises to improve pectoral fitness.
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Comparador activo: Specific training
Patients undergoing specific training during 12 weeks postoperatively
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Patients underwent specific training exercises to improve pectoral fitness.
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Sin intervención: No intervention
No specific treatment was assigned to these patients postoperatively
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Satisfaction degree. 7-points Likert scale was used for the quantification.
Periodo de tiempo: 12 weeks of treatment
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The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.
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12 weeks of treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jaime Ruiz-Tovar, MD, PhD, Hospital General Elche
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HURJC2015-02
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