Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer
Primary Purpose
Breast Cancer, Complications, Seroma
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Non drains will be placed during operation
Closed suction drainage
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Surgery, Complications, Drainage, Seroma
Eligibility Criteria
Inclusion Criteria:
- Stage I and II breast cancer patients
- Will be submitted to breast conserving therapy, with full axillary lymphadenectomy
Exclusion Criteria:
- diabetes
Sites / Locations
- Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
- Mastology Program of Federal University of Goias
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non drainage arm
Drainage arm
Arm Description
No drains will be placed during operation
Closed suction drains will be placed during operation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Serous fluid
The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced
Full Information
NCT ID
NCT01267552
First Posted
December 27, 2010
Last Updated
December 27, 2010
Sponsor
Universidade Federal de Goias
Collaborators
Araujo Jorge Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01267552
Brief Title
Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer
Official Title
Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal de Goias
Collaborators
Araujo Jorge Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Complications, Seroma
Keywords
Breast cancer, Surgery, Complications, Drainage, Seroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non drainage arm
Arm Type
Experimental
Arm Description
No drains will be placed during operation
Arm Title
Drainage arm
Arm Type
Active Comparator
Arm Description
Closed suction drains will be placed during operation
Intervention Type
Procedure
Intervention Name(s)
Non drains will be placed during operation
Other Intervention Name(s)
No drainage
Intervention Description
Non drains will be placed during operation
Intervention Type
Procedure
Intervention Name(s)
Closed suction drainage
Intervention Description
Closed suction drainage will be placed during operation
Primary Outcome Measure Information:
Title
Safety
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serous fluid
Description
The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced
Time Frame
6 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I and II breast cancer patients
Will be submitted to breast conserving therapy, with full axillary lymphadenectomy
Exclusion Criteria:
diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruffo Freitas-Junior, PhD
Organizational Affiliation
Universidade Federal de Goias
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luiz Fernando J Ribeiro, PhD
Organizational Affiliation
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605070
Country
Brazil
Facility Name
Mastology Program of Federal University of Goias
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605070
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
28793003
Citation
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.
Results Reference
derived
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Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer
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