Clinical trial NCT05029947: Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms
Official title: Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms - An Analysis of Standardized Outcome References From an International Multicentre Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysm
Aneurysm, Brain
Aneurysm Cerebral
Aneurysm of Cerebral Artery
Aneurysm, Intracranial
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete occlusion of aneurysm
timeFrame: up to 6 months
measure: Retreatment of aneurysm
timeFrame: up to 6 months
measure: Mortality
timeFrame: up to 6 months
Secondary outcomes:
measure: Chronic subdural hematoma
timeFrame: up to 6 months
measure: Stroke
timeFrame: up to 6 months
measure: Cerebral vasospasm
timeFrame: up to 6 months
measure: Intracerebal haemorrhage
timeFrame: up to 6 months
measure: New neurological deficit
timeFrame: up to 6 months
measure: Modified Rankin Score
timeFrame: up to 6 months
measure: Glasgow Outcome Scale
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Lasse Dührsen, MD
role: PRINCIPAL_INVESTIGATOR
References: