Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Microsurgical Clipping of Unruptured Intracranial Aneurysm


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Microsurgical Clipping of Unruptured Intracranial Aneurysm|Microsurgical Clipping of Unruptured Intracranial Aneurysm|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete occlusion of aneurysm | Aneurysm remnant in CT scan or angiography | up to 6 months | 
| Retreatment of aneurysm | Necessity of retreatment in endovascular or microsurgical technique | up to 6 months | 
| Mortality | Death of the patient | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic subdural hematoma | Development of chronic subdural hepatoma requiring intervention | up to 6 months | 
| Stroke | Occurrence of ischemic stroke | up to 6 months | 
| Cerebral vasospasm | Occurrence of cerebral vasospasm | up to 6 months | 
| Intracerebal haemorrhage | Occurrence of intracerebral haemorrhage related to aneurysm treatment | up to 6 months | 
| New neurological deficit | None, motor deficit, sensory deficit, aphasie | up to 6 months | 
| Modified Rankin Score | Difference of mRS compared to preoperative status | up to 6 months | 
| Glasgow Outcome Scale | From 1 (death) to 5 (low disability) | up to 6 months |