Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Lymphedema Perioperative/Postoperative Complications |
Procedure: management of therapy complications |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | Optimum Drainage of the Axilla After Lymph Node Dissection: A Randomized Prospective Study |
| Study Start Date: | November 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Royal Marsden NHS Foundation Trust - London | |
| London, England, United Kingdom, SW3 6JJ | |
| Royal Marsden NHS Foundation Trust - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Study Chair: | Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005600 History of Changes |
| Other Study ID Numbers: | CDR0000067713, RMNHS-1489, EU-20004 |
| Study First Received: | May 2, 2000 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I breast cancer stage II breast cancer lymphedema perioperative/postoperative complications |
Additional relevant MeSH terms:
|
Breast Neoplasms Lymphedema Postoperative Complications Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013