Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Complications; Seroma
• Interventions: Procedure: Non drains will be placed during operation; Procedure: Closed suction drainage

• Registration Number: NCT01267552
• Lead Sponsor: Universidade Federal de Goias

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.

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2007-09
• Study Completion: 2007-12
• Status Verified: 2010-07
• Study First Submitted: 2010-12-27
• Study First Submitted QC: 2010-12-27
• Last Update Submitted: 2010-12-27
• Study First Posted: 2010-12-28
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

• diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non drainage arm	Non drains will be placed during operation	No drains will be placed during operation
Drainage arm	Closed suction drainage	Closed suction drains will be placed during operation

Primary Outcome Measures

Name	Time	Method
Safety	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

Name	Time	Method
Serous fluid	6 months	The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced

Trial Locations

Locations (2)

Mastology Program of Federal University of Goias; 🇧🇷 Goiania, Goias, Brazil

Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias; 🇧🇷 Goiania, Goias, Brazil