Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carotid Stenosis
• Intervention / Treatment: Procedure: Carotid Surgery in patients with symptomatic or asymptomatic stenosis

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86156
    • University Hospital Augsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Carotid Surgery in patients with symptomatic or asymptomatic stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of surgeons' gender team gender and patients gender on procedure time	Duration of surgery measured in minutes	0-30 days
The impact of surgeons' gender team gender and patients gender on the length of stay	length of stay in days	0-30 days

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Collaborators: Epidemiology, Faculty of Medicine, University of Augsburg
• Investigators: Study Chair: Alexander Hyhlik-Duerr, Prof., University Hospital Augsburg Vascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Apoplexy; Carotid Artery; Surgical outcome; Gender specific outcome; Surgeon gender
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: CAROTIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: anonymous study design

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No