Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study
18 Years
N/A
Female
Breast Cancer, Lymphedema, Perioperative/Postoperative Complications
Trial Information
Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000067713
NCT ID:
NCT00005600
Start Date:
November 1997
Completion Date:
Related Keywords:
- Breast Cancer
- Lymphedema
- Perioperative/Postoperative Complications
- stage I breast cancer
- stage II breast cancer
- lymphedema
- perioperative/postoperative complications
- Breast Neoplasms
- Lymphedema
- Postoperative Complications
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