Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer
Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
2 other identifiers
interventional
240
1 country
2
Brief Summary
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jul 2000
Longer than P75 for phase_2 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 27, 2010
CompletedFirst Posted
Study publicly available on registry
December 28, 2010
CompletedDecember 28, 2010
July 1, 2010
7.2 years
December 27, 2010
December 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Serous fluid
6 months
Study Arms (2)
Non drainage arm
EXPERIMENTALNo drains will be placed during operation
Drainage arm
ACTIVE COMPARATORClosed suction drains will be placed during operation
Interventions
Non drains will be placed during operation
Eligibility Criteria
You may qualify if:
- Stage I and II breast cancer patients
- Will be submitted to breast conserving therapy, with full axillary lymphadenectomy
You may not qualify if:
- diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Federal de Goiaslead
- Araujo Jorge Hospitalcollaborator
Study Sites (2)
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Goiânia, Goiás, 74605070, Brazil
Mastology Program of Federal University of Goias
Goiânia, Goiás, 74605070, Brazil
Related Publications (1)
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.
PMID: 28793003DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruffo Freitas-Junior, PhD
Universidade Federal de Goias
- STUDY CHAIR
Luiz Fernando J Ribeiro, PhD
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 27, 2010
First Posted
December 28, 2010
Study Start
July 1, 2000
Primary Completion
September 1, 2007
Study Completion
December 1, 2007
Last Updated
December 28, 2010
Record last verified: 2010-07