- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03273348
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Breast cancer is the most common cancer in women throughout the world (FerlayJ.,2010) .
The overarching principle guiding surgical management of women with breast cancer remains the oncological safety. The mainstay of satisfactory local control continues to be adequate clearance of the primary tumour and involved axillary lymph nodes. Improvements in understanding of tumour biology have enabled the risk of loco-regional recurrence and distant events to be further reduced by adjuvant, or neo-adjuvant, radiotherapy and systemic treatments. In keeping with this, breast conserving therapy has become well established as the treatment of choice for most women with early breast cancer . However, approximately one-third of women still undergo mastectomy, either due to patient preference or in cases where breast conservation is not oncologically or aesthetically compatible with the size or distribution of disease. (Reefy et al; 2010)
The primary aim of BCS is preservation of the breast while adhering to oncologic principles, with the secondary objective to provide breast aesthetics. In recent years, with advances in early detection and adjuvant therapy life expectancy has prolonged in breast cancer prolonged and quality of life issues have gained importance (Veiga DF.,2010)
Skin sparing mastectomy involves the en-bloc removal of all glandular tissue including the nipple-areola complex and in some cases adjacent biopsy scars and skin overlying superficial tumours. In contrast to conventional mastectomy, there is maximal preservation of the remaining breast skin envelope and infra-mammary fold that facilitate immediate breast reconstruction with autologous tissue and/or prosthetic implants by utilising the native skin envelope to optimise the contour, texture, colour and scarring of the reconstructed breast. (Cunnick and Mokbel; 2004).
Due to the positive results obtained in the surgical treatment of breast cancer, the prevalence of this technique is increasing throughout the world and our country. There was an approximately 2.3-fold increase in OBS publications over the last five years (Losken A et al.,2014)
Surgical planning and timing of reconstruction should include breast volume, tumor location, the extent of glandular tissue resected, enabling each patient to receive an individual "custom-made" reconstruction. With immediate oncoplastic approach, the surgical process is smooth since oncological and reconstructive surgery can be associated in one operative setting. Additionally, because there is no scar and fibrosis tissue, breast reshaping is easier, and the aesthetic is improved (Munhoz AM et al .,2011) When considering a patient for an oncoplastic breast conserving procedure, the following points must be considered:
- volume of tissue to be excised;
- tumour location;
- breast size and glandular density;
- patient related risk factors, particularly smoking, obesity, diabetes, previous surgery;
- adjuvant therapies. Excision volume is the single, most predictive factor for breast deformity (Clough KB et al .,2010).
Recently, several studies have contributed to the evidence base supporting the oncological adequacy of skin sparing mastectomy in selected early-stage breast cancer , excluding inflammatory breast cancer and tumours with extensive involvement of the skin. In this study the oncological safety, post-operative morbidity and patients' satisfaction with skin sparing mastectomy and immediate breast reconstruction will be evaluated in a prospective cohort of women with early-stage breast cancer. (Cunnick and Mokbel; 2004) Skin sparing mastectomy and immediate breast reconstruction is particularly attractive for women with ductal Carcinoma In-Situ in view of the fact that post-mastectomy radiotherapy is not given to the reconstructed breast and the risk of loco-regional recurrence is very low. (Spiegel and Butler; 2003)
Most women who will undergo skin sparing mastectomy and immediate breast reconstruction for early-stage breast cancer will not require post-mastectomy radiotherapy. However, post-mastectomy radiotherapy has been shown to reduce loco-regional recurrence and improve survival for patients with three or more involved regional lymph nodes or tumors >5 cm. (Recht and Edge; 2003) Mastectomy can also be indicated in several non-invasive conditions. Ductal Carcinoma In-Situ may necessitate mastectomy when the lesions are extensive, multi-centric or recurrent, however, patients request to be managed in this way. Mastectomy for ductal Carcinoma In-Situ is associated with cure rates in excess of 98%. (Mokbel; 2003)
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Assiut, Egipto
- Assiut University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The study will include 30 women with early-stage breast cancer treated at general surgery department, Assuit University Hospitals
- For all patients an informed consent for their inclusion in the study including the use of images will be obtained.
- Selection criteria include women with a pre-operative diagnosis (clinical examination, imaging and needle biopsy) of Tis, T1 and T2 tumours without extensive skin involvement.
Exclusion Criteria:
• contraindaction for general anesthesia
- Positive margin requiring mastectomy
- Insufficient remaining breast volume
- Diffuse microcalcifications
- Multicentric tumor?
- Inflammatory breast cancer
- Previous radiotherapy
- Concomitant disease ( Diabetes, smoking )
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: oncoplastic breast surgery
This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer .
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, Skin sparing mastectomy and immediate breast reconstruction will be conducted to all women included in the study, transverse rectus abdominis musculocutaneous flap recostruction and latissimus dorsi myocutaneous pedicle-flap with and without implant
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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oncological safety
Periodo de tiempo: for 2 weaks
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the pathological report postoperative reveals safety free margins
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for 2 weaks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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tasa de mortalidad
Periodo de tiempo: hasta 3 meses postoperatorio para cada caso
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número de muertes intraoperatorias y posoperatorias relacionadas con la cirugía
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hasta 3 meses postoperatorio para cada caso
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postoperative recurrence of malignany
Periodo de tiempo: assess for 1 year postoperative
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follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance
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assess for 1 year postoperative
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post operative skin edge ischemia
Periodo de tiempo: assess for 1 month postoperative
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look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge
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assess for 1 month postoperative
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
- Veiga DF, Veiga-Filho J, Ribeiro LM, Archangelo I Jr, Balbino PF, Caetano LV, Novo NF, Ferreira LM. Quality-of-life and self-esteem outcomes after oncoplastic breast-conserving surgery. Plast Reconstr Surg. 2010 Mar;125(3):811-7. doi: 10.1097/PRS.0b013e3181ccdac5.
- Losken A, Dugal CS, Styblo TM, Carlson GW. A meta-analysis comparing breast conservation therapy alone to the oncoplastic technique. Ann Plast Surg. 2014 Feb;72(2):145-9. doi: 10.1097/SAP.0b013e3182605598.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 17200114
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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