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Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment


Phase 2/Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer, Complications, Seroma

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Trial Information

Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment


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.


Inclusion Criteria:



- Stage I and II breast cancer patients

- Will be submitted to breast conserving therapy, with full axillary lymphadenectomy

Exclusion Criteria:

- diabetes

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Ruffo Freitas-Junior, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universidade Federal de Goias

Authority:

Brazil: Ethics Committee

Study ID:

Drains Trial

NCT ID:

NCT01267552

Start Date:

July 2000

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Complications
  • Seroma
  • Breast cancer
  • Surgery
  • Complications
  • Drainage
  • Seroma
  • Breast Neoplasms
  • Seroma

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