- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
England
-
London, England, United Kingdom, SW3 6JJ
- Royal Marsden NHS Foundation Trust - London
-
Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067713
- RMNHS-1489
- EU-20004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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