NCT00005600

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer
• Lymphedema
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	management of therapy complications

Timeline

• Start date: 1997-11-01
• First posted: 2003-01-27
• Last updated: 2013-11-06

Locations

2 sites across 1 country: United Kingdom