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Completed

NCT Number: NCT01267552

Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Complications Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Seroma Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias, Goiânia, Goiás, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • diabetes

Treatment and study plan

Non drains will be placed during operation

Procedure

Non drains will be placed during operation

Other names: No drainage

Closed suction drainage

Procedure

Closed suction drainage will be placed during operation

Primary outcomes

  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 outcomes

  1. Serous fluid

    Time frame: 6 months

    The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Collaborators

  • Araujo Jorge Hospital

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Dec 28, 2010
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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