Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

December 27, 2010 updated by: Universidade Federal de Goias

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serous fluid
Time Frame: 6 months
The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 27, 2010

First Submitted That Met QC Criteria

December 27, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Estimate)

December 28, 2010

Last Update Submitted That Met QC Criteria

December 27, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Drains Trial
  • Drains trial01/2007 (Registry Identifier: FAPEG 01/2007)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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