Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Araujo Jorge Hospital
Information provided by:
Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT01267552
First received: December 27, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Goias:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced


Enrollment: 240
Study Start Date: July 2000
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Closed suction drainage

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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267552

Locations
Brazil
Mastology Program of Federal University of Goias
Goiania, Goias, Brazil, 74605070
Hospital Araujo Jorge, Associacao de Combate ao Cancer em 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

No publications provided

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
Study First Received: December 27, 2010
Last Updated: December 27, 2010
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on April 15, 2014