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

Breast Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Perioperative/Postoperative Complications
• Postoperative Complications

• NCT number: NCT00005600
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1997