Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: The use of axillary drains may help to prevent complications following axillary lymph node dissection. PURPOSE: This randomized clinical trial is comparing three methods of axillary drainage to see how well they work following lymph node dissection in women with stage I or stage II breast cancer.

Detailed Description
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OBJECTIVES: Compare high vacuum drainage vs low vacuum drainage vs simple tube drainage in patients undergoing axillary surgery for stage I or II breast cancer. OUTLINE: This is a randomized study. Patients undergo axillary dissection, then are randomized to one of three axillary drainage systems. Arm I: Patients receive high vacuum drainage. Arm II: Patients receive low vacuum drainage. Arm III: Patients receive simple tube drainage (no vacuum). All drains are removed when daily volumes are below 30 mL or at 5 days after surgery, regardless of drain volume. Patients are followed at day 10 and at 3 months. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Official Title
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Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study

Conditions
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Lymphedema, Breast Cancer, Perioperative/Postoperative Complications

Intervention / Treatment
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* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of resectable stage I or II breast cancer Planned primary surgery of level II or III axillary dissection in association with one of the following: Wide local excision (may be done through separate incision) No breast surgery Bilateral surgery allowed No prior mastectomy No immediate breast reconstruction using implants, latissimus dorsi, or rectus abdominus myocutaneous flaps at primary operation Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No prior axillary surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: management of therapy complications|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, lymphedema, perioperative/postoperative complications