- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00859157
Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known whether tumescent mastectomy or standard mastectomy results in less pain in women with breast cancer.
PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer.
Secondary
- To compare the total time of operation from incision to completion of wound closure.
- To compare the time of operation from first incision to completion of skin flaps.
- To compare the total estimated blood loss.
- To compare the number of days the Jackson-Pratt drain is left in place under skin flaps with wound drainage > 30 mL/24 hours.
- To compare the incidence of wound complications such as skin necrosis, hematoma, cellulitis, abscess, and seroma between groups.
OUTLINE: Patients are grouped according to which surgeon provided their evaluation and treatment recommendations.
- Group 1: Patients undergo standard mastectomy.
- Group 2: Patients undergo tumescent mastectomy. All patients receive standardized post-operative pain management comprising morphine sulfate for analgesia or an equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a comparable amount of another narcotic/acetaminophen combination) every 6 hours as needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
-
-
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
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
- Invasive (ductal or lobular) breast cancer
- In situ (ductal) breast cancer
- Stage 0-III disease
- Localized disease
- Candidate for curative mastectomy and selected mastectomy or modified radical mastectomy for surgical option of treatment at the University of California Davis Medical Center
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- WBC ≥ 1,500/mm^3
- Platelet count ≥ 90,000/mm^3
- PT/PTT ≤ upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No NYHA cardiac disease class III-IV
- Cancer survivors must have undergone potentially curative therapy for all prior malignancies with no evidence of prior malignancy within the last 5 years, except for effectively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix treated by surgery alone, or lobular carcinoma in situ of the breast treated by surgery alone
- Body Mass Index ≤ 40
PRIOR CONCURRENT THERAPY:
- No prior major breast surgery, including breast augmentation or reduction surgery
- No preoperative chemotherapy or radiotherapy
- No concurrent immediate breast reconstruction
- No concurrent bilateral mastectomy
- No concurrent narcotic pain medication
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Group 1
Patients undergo standard mastectomy.
|
Patients undergo tumescent or standard mastectomy
|
|
Group 2
Patients undergo tumescent mastectomy.
|
Patients undergo tumescent or standard mastectomy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Post-operative pain at 1 and at 7-10 days after mastectomy
Periodo de tiempo: 7-10 days
|
7-10 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of acetaminophen/oxycodone tablets taken
Periodo de tiempo: 7-10 days after surgery
|
7-10 days after surgery
|
|
Total time of operation from breast incision to completion of wound closure
Periodo de tiempo: Day of surgery
|
Day of surgery
|
|
Time of operation from first incision to completion of both superior and inferior skin flaps
Periodo de tiempo: Day of surgery
|
Day of surgery
|
|
Estimated blood loss
Periodo de tiempo: Day of surgery
|
Day of surgery
|
|
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
Periodo de tiempo: 7-10 days after surgery
|
7-10 days after surgery
|
|
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively
Periodo de tiempo: Up to 10 days after surgery
|
Up to 10 days after surgery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Steve R. Martinez, MD, University of California, Davis
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- cáncer de mama en estadio IIIA
- cáncer de mama en estadio IIIB
- dolor
- cáncer de mama en estadio II
- cáncer de mama en estadio IA
- cáncer de mama en estadio IB
- carcinoma ductal de mama in situ
- carcinoma ductal de mama invasivo
- carcinoma lobulillar de mama invasivo
- complicaciones perioperatorias/postoperatorias
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 246600
- UCD-CCSO001
- 200816282
- CDR0000633754 (Otro identificador: UC Davis)
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