Clinical trial NCT06485102: Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons
Official title: Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carotid Stenosis
Keywords: Carotid Artery
Apoplexy
Surgical outcome
Gender specific outcome
Surgeon gender
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
Collaborators: name: Epidemiology, Faculty of Medicine, University of Augsburg
First posted: 2024-07-03
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: Data about physician gender having impact on the treatment quality of a patient first appeared in 1999, the publication being about patients with breast cancer. This discussion was resumed in 2016 when Y. Tsugawa et. al showed that female doctors have, in comparison to male doctors, better treatment results. Primary outcomes for the study were mortality and readmissions, which were lower if the treatment has been done by a female doctor. Until today, there are only a few reports about the role of physician gender, especially that of surgeons, in the treatment quality. Studies like the ones from Blohm et. al and Wallis et. al show that female surgeons have a better outcome and a lower mortality, 30 days after the surgery. Wallis et. al also showed that the correlation between male surgeons and female patients have the worst results\].

None of the studies that were written until today focussed on carotid surgery. Since 2012, in Germany, the surgical treatment of carotid stenosis has an established quality assurance, with specific documentation and a standard surgical course of action. This is why we consider that this surgery is especially suitable for comparison of results, depending on surgeon genders.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- No quality assurance

Primary outcomes:
measure: The impact of surgeons' gender, team gender and patients gender on postoperative apoplexy
timeFrame: 0-30 days
measure: The impact of surgeons' gender team gender and patients gender on postoperative peripheral nerve lesions
timeFrame: 0-30 days
measure: The impact of surgeons' gender team gender and patients gender on reinterventions
timeFrame: 0-30 days
measure: The impact of surgeons' gender team gender and patients gender on procedure related death
timeFrame: 0-30 days
Secondary outcomes:
measure: The impact of surgeons' gender team gender and patients gender on procedure time
timeFrame: 0-30 days
measure: The impact of surgeons' gender team gender and patients gender on the length of stay
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
Study officials:
affiliation: University Hospital Augsburg Vascular Surgery
name: Alexander Hyhlik-Duerr, Prof.
role: STUDY_CHAIR
References: