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Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01267552
Enrollment
240
Registered
2010-12-28
Start date
2000-07-31
Completion date
2007-12-31
Last updated
2010-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Complications, Seroma

Keywords

Breast cancer, Surgery, Complications, Drainage, Seroma

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.

Interventions

PROCEDURENon drains will be placed during operation

Non drains will be placed during operation

PROCEDUREClosed suction drainage

Closed suction drainage will be placed during operation

Sponsors

Araujo Jorge Hospital
CollaboratorOTHER
Universidade Federal de Goias
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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

* diabetes

Design outcomes

Primary

MeasureTime frameDescription
Safety6 monthsThe 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

MeasureTime frameDescription
Serous fluid6 monthsThe number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026