Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005600
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-05-02
Brief Title:
Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Optimum Drainage of the Axilla After Lymph Node Dissection A Randomized Prospective Study
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20004 | None | None | None |
| RMNHS-1489 | None | None | None |