Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00005600|
Recruitment Status : Unknown
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lymphedema Perioperative/Postoperative Complications||Procedure: management of therapy complications||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|Official Title:||Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study|
|Study Start Date :||November 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005600
|Royal Marsden NHS Foundation Trust - London|
|London, England, United Kingdom, SW3 6JJ|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)||Royal Marsden NHS Foundation Trust|