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| ID | Type | Description | Link |
|---|---|---|---|
| UCD-CCSO001 | |||
| 200816282 | |||
| CDR0000633754 | Other Identifier | UC Davis |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are grouped according to which surgeon provided their evaluation and treatment recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients undergo standard mastectomy. |
| |
| Group 2 | Patients undergo tumescent mastectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | Patients undergo tumescent or standard mastectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain at 1 and at 7-10 days after mastectomy | 7-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of acetaminophen/oxycodone tablets taken | 7-10 days after surgery | |
| Total time of operation from breast incision to completion of wound closure | Day of surgery | |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
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:
PRIOR CONCURRENT THERAPY:
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Adult (age 18 or more) women with histologic diagnosis of stage 0, I, II, III breast cancer undergoing mastectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Steve R. Martinez, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
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| Time of operation from first incision to completion of both superior and inferior skin flaps |
| Day of surgery |
| Estimated blood loss | Day of surgery |
| Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours | 7-10 days after surgery |
| Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively | Up to 10 days after surgery |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| D011183 | Postoperative Complications |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |
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