NCT06485102

Brief Summary

This research will focus on the differences of the postoperative outcome for carotid surgery patients treated by either male or female surgeons. Since 2012, in Germany, the surgical treatment of carotid stenosis has an established quality assurance, making the thematic especially suitable for testing the surgical results of either male or female surgeons.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

January 29, 2024

Last Update Submit

June 26, 2024

Conditions

Carotid Stenosis

Keywords

Carotid ArteryApoplexySurgical outcomeGender specific outcomeSurgeon gender

Outcome Measures

Primary Outcomes (4)

  • The impact of surgeons' gender, team gender and patients gender on postoperative apoplexy

    stroke \[observed in a time frame of 30 days after the operation\]

    0-30 days

  • The impact of surgeons' gender team gender and patients gender on postoperative peripheral nerve lesions

    Impairment of peripheral cervial nerves \[observed in a time frame of 30 days after the operation\]

    0-30 days

  • The impact of surgeons' gender team gender and patients gender on reinterventions

    Number of patients with surgical revision

    0-30 days

  • The impact of surgeons' gender team gender and patients gender on procedure related death

    Number of patients who died following surgery

    0-30 days

Secondary Outcomes (2)

  • The impact of surgeons' gender team gender and patients gender on procedure time

    0-30 days

  • The impact of surgeons' gender team gender and patients gender on the length of stay

    0-30 days

Study Arms (1)

Patients undergoing surgery

A retrospective data collection will be conducted for all the patients, that between jan. 2012 and dec. 2023, were operated because of a carotid stenosis in the University Clinic for Vascular and Endovascular Surgery in Augsburg. This stenosis may have been symptomatic or asymptomatic. The surgery must respect the latest quality assurance for that period.

Procedure: Carotid Surgery in patients with symptomatic or asymptomatic stenosis

Interventions

Carotid Surgery in patients with symptomatic or asymptomatic stenosisPROCEDURE

Carotid Surgery in patients with symptomatic or asymptomatic stenosis

Patients undergoing surgery

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe impact of surgeons' gender on the postoperative outcomes. The impact of surgeons' team gender on the postoperative outcome. The connection between patients' gender and surgeons' gender regarding postoperative outcome.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A retrospective data collection will be conducted for all the patients, that between jan. 2012 and dec. 2023, were operated because of a carotid stenosis in the University Clinic for Vascular and Endovascular Surgery in Augsburg. This stenosis may have been symptomatic or asymptomatic. The surgery must respect the latest quality assurance for that period.

You may qualify if:

  • Age above 18 years
  • All the patients that had a carotid revascularisation between jan. 2012 and dec. 2023.

You may not qualify if:

  • \- No quality assurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Augsburg

Augsburg, 86156, Germany

Location

MeSH Terms

Conditions

Carotid StenosisStroke

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Alexander Hyhlik-Duerr, Prof.

    University Hospital Augsburg Vascular Surgery

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

July 3, 2024

Study Start

March 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

anonymous study design

Locations

DE(1)