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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 2, 2000
Last updated: November 5, 2013
Last verified: December 2005

May 2, 2000
November 5, 2013
November 1997
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Complete list of historical versions of study NCT00005600 on Archive Site
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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

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.


  • 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.

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Allocation: Randomized
Primary Purpose: Supportive Care
  • Breast Cancer
  • Lymphedema
  • Perioperative/Postoperative Complications
Procedure: management of therapy complications
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • See Disease Characteristics
  • No prior axillary surgery
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Royal Marsden NHS Foundation Trust
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Study Chair: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden NHS Foundation Trust
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP