Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05346289
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2022-04-20
Brief Title:
Elective Treatment Rates and Surgical Non-eligibility Among Men and Women With Intact Abdominal Aortic Aneurysms
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Elective Treatment Rates Among Patients With Intact Abdominal Aortic Aneurysms -Patient- and Aneurysm-related Factors as Determinants of Surgical Non-eligibility in Women and Men
Status:
COMPLETED
Status Verified Date:
2022-11
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:
The overall aim is to determine the frequency by which women and men with intact abdominal aortic aneurysms AAA are treated with elective surgery at three vascular outpatient clinics in Europe and to investigate whether the reasons to refrain from elective surgery differ between the sexes
Detailed Description:
Abdominal aortic aneurysm AAA is a local widening of the infrarenal aorta 1 The natural history of AAA is progressive and may lead to rupture a true surgical emergency with a mortality rate of 100 without immediate treatment Men are more commonly affected 2 3 however women demonstrate a notably elevated risk of rupture 4 5 and constitute up to 13 of all ruptures 4 5 One plausible explanation could be a sex discrepancy in elective treatment rates
There is both national and international evidence implying that AAA treatments both elective and emergent are withheld among women 6-14 Studies on elective treatment rates are especially scarce as the vast majority of databases and vascular registries only include data on treated AAA patients A few single-center studies from the UK 6 7 15 and one meta-analysis 8 have recorded lower treatment rates among women We have recently analyzed the issue of elective treatment rates in our group using a population-based approach manuscript submitted Of all patients diagnosed with an intact AAA in Sweden during 2001-2015 n32 393 21 women a crude proportion as high as 60 did not proceed to receive surgical treatment The proportion of untreated women 67 surpassed that of men 59 In the multivariate analyses female sex and advanced age emerged as the strongest predictors for remaining untreated despite other characteristics such as comorbidities civil status and individual disposable household income The median time from diagnosis to treatment for those treated was surprisingly short at 16 years
The foremost intention-to-treat variable that determines the indication for elective surgery is the maximal diameter of the aneurysm 55 mm in men 50 mm in women 16 17 Population-based investigations while comprehensive fall short in terms of aneurysm-specific data Therefore these analyses assume comparable diameter distributions and similar morphology for men and women Similarly longitudinal follow-up data from the clinical setting such as records of patients wishes and physiological preoperative examinations cannot be extracted for the purpose of nationwide analyses Thus the question remains whether the observed gender gap in elective treatment rates persists after detailed considerations of patient- and aneurysm-specific characteristics A discrepancy in elective treatment rates could also lead to different long-term outcomes with higher rupture and mortality rates among women
There is both national and international evidence implying that AAA treatments both elective and emergent are withheld among women 6-14 Studies on elective treatment rates are especially scarce as the vast majority of databases and vascular registries only include data on treated AAA patients A few single-center studies from the UK 6 7 15 and one meta-analysis 8 have recorded lower treatment rates among women We have recently analyzed the issue of elective treatment rates in our group using a population-based approach manuscript submitted Of all patients diagnosed with an intact AAA in Sweden during 2001-2015 n32 393 21 women a crude proportion as high as 60 did not proceed to receive surgical treatment The proportion of untreated women 67 surpassed that of men 59 In the multivariate analyses female sex and advanced age emerged as the strongest predictors for remaining untreated despite other characteristics such as comorbidities civil status and individual disposable household income The median time from diagnosis to treatment for those treated was surprisingly short at 16 years
The foremost intention-to-treat variable that determines the indication for elective surgery is the maximal diameter of the aneurysm 55 mm in men 50 mm in women 16 17 Population-based investigations while comprehensive fall short in terms of aneurysm-specific data Therefore these analyses assume comparable diameter distributions and similar morphology for men and women Similarly longitudinal follow-up data from the clinical setting such as records of patients wishes and physiological preoperative examinations cannot be extracted for the purpose of nationwide analyses Thus the question remains whether the observed gender gap in elective treatment rates persists after detailed considerations of patient- and aneurysm-specific characteristics A discrepancy in elective treatment rates could also lead to different long-term outcomes with higher rupture and mortality rates among women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None