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| ID | Type | Description | Link |
|---|---|---|---|
| Drains trial01/2007 | Registry Identifier | FAPEG 01/2007 |
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| Name | Class |
|---|---|
| Araujo Jorge Hospital | OTHER |
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To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.
The primary objective is to study the safety of not draining the axilla, considering the total number of patients without complication among breast cancer patients treated by means of conservative surgery and full axillary lymphadenectomy, with or without axillary drainage.
The secondary objectives will be the numbers of aspiration punctures, volumes of fluid aspirated and the total volumes of fluid produced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non drainage arm | Experimental | No drains will be placed during operation |
|
| Drainage arm | Active Comparator | Closed suction drains will be placed during operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non drains will be placed during operation | Procedure | Non drains will be placed during operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The safety of not draining the axilla, will be considered by the total number of patients without complication among breast cancer patients treated by means of breast conserving surgery and full axillary lymphadenectomy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serous fluid | The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruffo Freitas-Junior, PhD | Universidade Federal de Goias | Principal Investigator |
| Luiz Fernando J Ribeiro, PhD | Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias | Goiânia | Goiás | 74605070 | Brazil | ||
| Mastology Program of Federal University of Goias |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28793003 | Derived | Freitas-Junior R, Ribeiro LFJ, Moreira MAR, Queiroz GS, Esperidiao MD, Silva MAC, Pereira RJ, Zampronha RAC, Rahal RMS, Soares LR, Dos Santos DL, Thomazini MV, de Faria CFS, Paulinelli RR. Complete axillary dissection without drainage for the surgical treatment of breast cancer: a randomized clinical trial. Clinics (Sao Paulo). 2017 Jul;72(7):426-431. doi: 10.6061/clinics/2017(07)07. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Closed suction drainage | Procedure | Closed suction drainage will be placed during operation |
|
| Goiânia |
| Goiás |
| 74605070 |
| Brazil |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |