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

Not Applicable

• Conditions: Breast Cancer; Lymphedema; Perioperative/Postoperative Complications

• Registration Number: NCT00005600
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 1997-11
• Study First Submitted: 2000-05-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-12
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Royal Marsden NHS Foundation Trust - Surrey; 🇬🇧 Sutton, England, United Kingdom

Royal Marsden NHS Foundation Trust - London; 🇬🇧 London, England, United Kingdom