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Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

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ClinicalTrials.gov Identifier: NCT01267552
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : December 28, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.

Condition or disease Intervention/treatment Phase
Breast Cancer Complications Seroma Procedure: Non drains will be placed during operation Procedure: Closed suction drainage Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
Study Start Date : July 2000
Primary Completion Date : September 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Non drainage arm
No drains will be placed during operation
Procedure: Non drains will be placed during operation
Non drains will be placed during operation
Other Name: No drainage
Active Comparator: Drainage arm
Closed suction drains will be placed during operation
Procedure: Closed suction drainage
Closed suction drainage will be placed during operation


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Serous fluid [ Time Frame: 6 months ]
    The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267552


Locations
Brazil
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Goiania, Goias, Brazil, 74605070
Mastology Program of Federal University of Goias
Goiania, Goias, Brazil, 74605070
Sponsors and Collaborators
Universidade Federal de Goias
Araujo Jorge Hospital
Investigators
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
More Information

Responsible Party: Ruffo Freitas-Junior, Federal University of Goias
ClinicalTrials.gov Identifier: NCT01267552     History of Changes
Other Study ID Numbers: Drains Trial
Drains trial01/2007 ( Registry Identifier: FAPEG 01/2007 )
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: July 2010

Keywords provided by Universidade Federal de Goias:
Breast cancer
Surgery
Complications
Drainage
Seroma

Additional relevant MeSH terms:
Breast Neoplasms
Seroma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Inflammation
Pathologic Processes