- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03535012
Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options
Over the past 10 years, there have been substantial improvements in breast reconstruction by plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy. Advances in both microsurgery and implants have allowed for a wider variety of surgical methods, and procedural skills that minimize donor site complications have been developed.
With such satisfactory aesthetic results, interest has recently increased not only in breast reconstruction but also in sensory recovery. Due to the growing expectation of patients, sensory discomfort may decrease overall patient satisfaction with breast reconstruction despite good aesthetic results. Hence, for qualitative improvement of breast reconstruction surgery, efforts must be made to restore sensation in the reconstructed breast. There has been little research on the mechanism of sensory recovery despite its clinical importance. This study aimed to compare the degree of sensory recovery in the reconstructed breast using various reconstruction methods as well as to evaluate the status of neural regeneration with harvesting the tissues when nipple reconstruction is performed.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 03722
- Reclutamiento
- Department of Plastic Surgery, Yonsei University School of Medicine, Severance Hospital
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Contacto:
- Dongwon Lee, MD, Ph.D
- Número de teléfono: 82-2-2228-2215
- Correo electrónico: XYPHOSS@yuhs.ac
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Female adults over 20 years of age
- Patients who have undergone or plan to undergo total mastectomy and immediate breast reconstruction after the diagnosis of breast cancer (including carcinoma in situ)
- written consent to study participation
Exclusion Criteria:
- presence of neuropathy that may hinder accurate assessment of sensation
- presence of dermatological condition that may hinder accurate assessment of sensation
- inability to provide written consent
- decided by the research team to be unsuitable for this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Reconstruction using an implant
Immediate 2 stage implant based breast reconstruction after mastectomy.
All expanders are placed in the subpectoralis muscle using ADM as a sling.
After expansion of the tissue expander change to the permanent implant is performed.
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Reconstruction using abdominal tissue
immediate free DIEP flap breast reconstruction after mastectomy.
DIEP(deep inferior epigastric perforator) free flap was prepared and transferred to the breast pocket.
Microanastomosis was done under the microscopic magnification.
On sitting position, free flap was inset into breast pocket with confirming of satisfactory inflammatory fold.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sensory recovery in the reconstructed breast according to reconstructive options
Periodo de tiempo: 3 months (±1 month) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 3 months (±1 month) after immediate breast reconstruction surgery.
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3 months (±1 month) after immediate breast reconstruction surgery
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Sensory recovery in the reconstructed breast according to reconstructive options
Periodo de tiempo: 6 months (±1 month) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 6 months (±1 month) after immediate breast reconstruction surgery.
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6 months (±1 month) after immediate breast reconstruction surgery
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Sensory recovery in the reconstructed breast according to reconstructive options
Periodo de tiempo: 12 months (±2 months) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 12 months (±2 months) after immediate breast reconstruction surgery.
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12 months (±2 months) after immediate breast reconstruction surgery
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Sensory recovery in the reconstructed breast according to reconstructive options
Periodo de tiempo: 18 months (±2 months) after immediate breast reconstruction surgery
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Subjects will be followed up with quantitative sensory testing at 18 months (±2 months) after immediate breast reconstruction surgery.
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18 months (±2 months) after immediate breast reconstruction surgery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- 4-2015-1019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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