Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267552
• Other study ID #: Drains Trial
• Secondary ID: Drains trial01/2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 27, 2010
• Last updated: December 27, 2010
• Start date: July 2000
• Est. completion date: December 2007

Study information

• Verified date: July 2010
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Complications
• Seroma

Intervention

Procedure:
• Non drains will be placed during operation
Non drains will be placed during operation
• Closed suction drainage
Closed suction drainage will be placed during operation

Locations

Country	Name	City	State
Brazil	Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias	Goiania	Goias
Brazil	Mastology Program of Federal University of Goias	Goiania	Goias

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Goias	Araujo Jorge Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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	Yes
Secondary	Serous fluid	The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced	6 months	No