Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Safety
Study Overview
Brief Summary
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stage I and II breast cancer patients
- •Will be submitted to breast conserving therapy, with full axillary lymphadenectomy
Exclusion Criteria
- Not provided
Arms & Interventions
Non drainage arm
No drains will be placed during operation
Intervention: Non drains will be placed during operation (Procedure)
Drainage arm
Closed suction drains will be placed during operation
Intervention: Closed suction drainage (Procedure)
Outcomes
Primary Outcomes
Safety
Time Frame: 6 months
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
Secondary Outcomes
- Serous fluid(6 months)