Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

NCT ID: NCT01267552

Last Updated: 2010-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer Complications Seroma

Keywords

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Breast cancer Surgery Complications Drainage Seroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non drainage arm

No drains will be placed during operation

Group Type EXPERIMENTAL

Non drains will be placed during operation

Intervention Type PROCEDURE

Non drains will be placed during operation

Drainage arm

Closed suction drains will be placed during operation

Group Type ACTIVE_COMPARATOR

Closed suction drainage

Intervention Type PROCEDURE

Closed suction drainage will be placed during operation

Interventions

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Non drains will be placed during operation

Non drains will be placed during operation

Intervention Type PROCEDURE

Closed suction drainage

Closed suction drainage will be placed during operation

Intervention Type PROCEDURE

Other Intervention Names

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No drainage

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* diabetes
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Araujo Jorge Hospital

OTHER

Sponsor Role collaborator

Universidade Federal de Goias

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Goias

Principal Investigators

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Ruffo Freitas-Junior, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Goias

Luiz Fernando J Ribeiro, PhD

Role: STUDY_CHAIR

Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias

Locations

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Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias

Goiânia, Goiás, Brazil

Site Status

Mastology Program of Federal University of Goias

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

References

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Freitas-Junior R, Ribeiro LFJ, Moreira MAR, Queiroz GS, Esperidiao MD, Silva MAC, Pereira RJ, Zampronha RAC, Rahal RMS, Soares LR, Dos Santos DL, Thomazini MV, de Faria CFS, Paulinelli RR. Complete axillary dissection without drainage for the surgical treatment of breast cancer: a randomized clinical trial. Clinics (Sao Paulo). 2017 Jul;72(7):426-431. doi: 10.6061/clinics/2017(07)07.

Reference Type DERIVED
PMID: 28793003 (View on PubMed)

Other Identifiers

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Drains trial01/2007

Identifier Type: REGISTRY

Identifier Source: secondary_id

Drains Trial

Identifier Type: -

Identifier Source: org_study_id