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

Royal Marsden NHS Foundation Trust

Status: Unknown

Conditions: Breast Cancer; Perioperative/Postoperative Complications; Lymphedema

Treatments: Procedure: management of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT00005600

EU-20004

RMNHS-1489

CDR0000067713

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of resectable stage I or II breast cancer

• Planned primary surgery of level II or III axillary dissection in association with one of the following:

  • Wide local excision (may be done through separate incision)
  • No breast surgery
  • Bilateral surgery allowed

• No prior mastectomy

• No immediate breast reconstruction using implants, latissimus dorsi, or rectus abdominus myocutaneous flaps at primary operation

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics
• No prior axillary surgery