Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
This trial is active, not recruiting.
|Conditions||breast cancer, lymphedema, perioperative/postoperative complications|
|Treatment||management of therapy complications|
|Sponsor||Royal Marsden NHS Foundation Trust|
|Start date||November 1997|
|Trial identifier||NCT00005600, CDR0000067713, EU-20004, RMNHS-1489|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Primary purpose||supportive care|
Female participants at least 18 years old.
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
|Official title||Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study|
|Description||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.|
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