Carotid StenosisNCT06485102
Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons
An observational study of Carotid Stenosis, run by University Hospital Augsburg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Carotid Surgery in patients with symptomatic or asymptomatic stenosis
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age above 18 years
- All the patients that had a carotid revascularisation between jan. 2012 and dec. 2023.
Who cannot join
- No quality assurance
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Carotid Stenosis
- Being tested
- Carotid Surgery in patients with symptomatic or asymptomatic stenosis
- Keywords
- Carotid Artery, Apoplexy, Surgical outcome, Gender specific outcome, Surgeon gender
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Surgery in patients with symptomatic or asymptomatic stenosisProcedure or surgery
Carotid Surgery in patients with symptomatic or asymptomatic stenosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Carotid Surgery in patients with symptomatic or asymptomatic stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: 0-30 days
The impact of surgeons' gender team gender and patients gender on reinterventions
Number of patients with surgical revision
Measured: 0-30 days
The impact of surgeons' gender team gender and patients gender on procedure related death
Number of patients who died following surgery
Measured: 0-30 days
Secondary outcomes (2)
The impact of surgeons' gender team gender and patients gender on procedure time
Duration of surgery measured in minutes
Measured: 0-30 days
The impact of surgeons' gender team gender and patients gender on the length of stay
length of stay in days
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiology, Faculty of Medicine, University of Augsburg
- Responsible party
- Sponsor
- Investigators
- Alexander Hyhlik-Duerr, Prof., Study chair, University Hospital Augsburg Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485102
- Sponsor's protocol ID
- CAROTIS
- Status last verified
- Jun 2024
- First submitted
- 29 Jan 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymous study design
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons
- ClinicalTrials.gov ID
- NCT06485102
- Acronym / sponsor ID
- CAROTIS
- Conditions
- Carotid Stenosis
- Keywords
- Carotid Artery, Apoplexy, Surgical outcome, Gender specific outcome, Surgeon gender
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- Epidemiology, Faculty of Medicine, University of Augsburg
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery | – | Procedure: Carotid Surgery in patients with symptomatic or asymptomatic stenosisA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age above 18 years
- All the patients that had a carotid revascularisation between jan. 2012 and dec. 2023.
Key exclusion criteria (1 listed)
- No quality assurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Surgery in patients with symptomatic or asymptomatic stenosisCarotid Surgery in patients with symptomatic or asymptomatic stenosis | Procedure or surgery | Patients undergoing surgery |
Primary outcome
The impact of surgeons' gender, team gender and patients gender on postoperative apoplexy
Time frame: 0-30 days
stroke [observed in a time frame of 30 days after the operation]
The impact of surgeons' gender team gender and patients gender on postoperative peripheral nerve lesions
Time frame: 0-30 days
Impairment of peripheral cervial nerves [observed in a time frame of 30 days after the operation]
The impact of surgeons' gender team gender and patients gender on reinterventions
Time frame: 0-30 days
Number of patients with surgical revision
The impact of surgeons' gender team gender and patients gender on procedure related death
Time frame: 0-30 days
Number of patients who died following surgery
2 secondary outcomes
The impact of surgeons' gender team gender and patients gender on procedure time
Time frame: 0-30 days
The impact of surgeons' gender team gender and patients gender on the length of stay
Time frame: 0-30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. anonymous study design
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Hyhlik-Duerr, Prof. study chair
University Hospital Augsburg Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of surgeons' gender, team gender and patients gender on postoperative apoplexy (time frame: 0-30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.