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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005600

Enrollment

Unknown

Registered

2003-01-27

Start date

1997-11-30

Completion date

Unknown

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lymphedema, Perioperative/Postoperative Complications

Keywords

stage I breast cancer, stage II breast cancer, lymphedema, perioperative/postoperative complications

Brief 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.

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.

Interventions

PROCEDUREmanagement of therapy complications

Study design

Allocation

RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026