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