Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114088
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2005-06-13
Brief Title:
Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding STOP-DUB
Sponsor:
Agency for Healthcare Research and Quality AHRQ
Organization:
Agency for Healthcare Research and Quality AHRQ
Study Overview
Official Title:
Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding STOP-DUB
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
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:
STOP-DUB is a multicenter randomized clinical trial that is assessing the efficacy and effectiveness of hysterectomy versus endometrial ablation EA for dysfunctional uterine bleeding DUB in women for whom medical management has not provided relief
Detailed Description:
The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding STOP-DUB is a multicenter randomized clinical trial that assessed the efficacy and effectiveness of hysterectomy versus endometrial ablation EA for dysfunctional uterine bleeding DUB in women for whom medical management has not provided relief Institutional review board-approved study sites included the coordinating center chairs office the American College of Obstetricians and Gynecologists and 33 clinical centers in the United States and Canada STOP-DUB enrolled 1 237 eligible patients for whom medical treatment had not been successful and who were randomized to either hysterectomy or EA and 2 an observational cohort of 139 patients who were provisionally ineligible or who were eligible but did not wish to be randomized Enrollment began November 25 1997 and ended June 30 2001 Randomized women were followed using telephone interviews at least 2 years and observational women were followed a maximum of 6 months We also collected information on return clinical center visits and hospital bills from the sites directly The primary outcome addressed by the randomized trial is the impact of surgery on bleeding pain fatigue and the major problem symptom that led the woman to seek treatment for her condition measured 1 year following surgery Additional outcomes included the impact of surgery at time points after 1 year changes in quality of life activity limitation sexual functioning and urinary incontinence surgical complications additional surgery and resource utilization The costs and the relative cost-effectiveness of the two surgeries will be calculated The main scientific objective for the observational study was to examine changes over time in terms of treatment selected DUB-related symptoms and quality of life Enrolled women signed an informed consent to participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None