Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

Universidade Federal de Goias

Status and phase: Completed; Phase 3; Phase 2

Conditions: Breast Cancer; Seroma; Complications

Treatments: Procedure: Non drains will be placed during operation; Procedure: Closed suction drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT01267552

Drains trial01/2007 (Registry Identifier)

Drains Trial

Details and patient eligibility

About

To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.

Full description

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.

Enrollment: 240 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage I and II breast cancer patients
• Will be submitted to breast conserving therapy, with full axillary lymphadenectomy

Exclusion criteria

• diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Non drainage arm

Experimental group

Description:

No drains will be placed during operation

Treatment:

Procedure: Non drains will be placed during operation

Drainage arm

Active Comparator group

Description:

Closed suction drains will be placed during operation

Treatment:

Procedure: Closed suction drainage