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Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms

Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms - An Analysis of Standardized Outcome References From an International Multicentre Cohort

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05029947
Enrollment
3000
Registered
2021-09-01
Start date
2016-01-01
Completion date
2022-12-31
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm, Aneurysm, Brain, Aneurysm Cerebral, Aneurysm, Intracranial, Aneurysm of Cerebral Artery

Brief summary

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (UIA).

Detailed description

Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. In the past years, the concept of benchmarking attaches greater importance in the field of healthcare, especially in surgery. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. The aim of our study is the establishment of robust and standardized outcome references after microsurgical clipping of unruptured intracranial aneurysms. After successful implementation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.

Interventions

PROCEDUREMicrosurgical Clipping of Unruptured Intracranial Aneurysm

Microsurgical Clipping of Unruptured Intracranial Aneurysm

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm * High-volume centers with ≥40 cases per year during the study period

Exclusion criteria

* Treatment following subarachnoid haemorrhage * Clipping following an incomplete occlusion after previous treatment

Design outcomes

Primary

MeasureTime frameDescription
Complete occlusion of aneurysmup to 6 monthsAneurysm remnant in CT scan or angiography
Retreatment of aneurysmup to 6 monthsNecessity of retreatment in endovascular or microsurgical technique
Mortalityup to 6 monthsDeath of the patient

Secondary

MeasureTime frameDescription
Intracerebal haemorrhageup to 6 monthsOccurrence of intracerebral haemorrhage related to aneurysm treatment
New neurological deficitup to 6 monthsNone, motor deficit, sensory deficit, aphasie
Chronic subdural hematomaup to 6 monthsDevelopment of chronic subdural hepatoma requiring intervention
Glasgow Outcome Scaleup to 6 monthsFrom 1 (death) to 5 (low disability)
Modified Rankin Scoreup to 6 monthsDifference of mRS compared to preoperative status
Strokeup to 6 monthsOccurrence of ischemic stroke
Cerebral vasospasmup to 6 monthsOccurrence of cerebral vasospasm

Countries

Germany

Contacts

Primary ContactRichard Drexler, MD
r.drexler@uke.de004915222816461
Backup ContactLasse Dührsen, MD
l.duehrsen@uke.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026