Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms

Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029947
• Other study ID #: BenchmarkUIA
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Richard Drexler, MD
• Phone: 004915222816461
• Email: r.drexler[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Cerebral
• Aneurysm, Brain
• Aneurysm, Intracranial
• Intracranial Aneurysm

Intervention

Procedure:
• Microsurgical Clipping of Unruptured Intracranial Aneurysm
Microsurgical Clipping of Unruptured Intracranial Aneurysm

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete occlusion of aneurysm	Aneurysm remnant in CT scan or angiography	up to 6 months
Primary	Retreatment of aneurysm	Necessity of retreatment in endovascular or microsurgical technique	up to 6 months
Primary	Mortality	Death of the patient	up to 6 months
Secondary	Chronic subdural hematoma	Development of chronic subdural hepatoma requiring intervention	up to 6 months
Secondary	Stroke	Occurrence of ischemic stroke	up to 6 months
Secondary	Cerebral vasospasm	Occurrence of cerebral vasospasm	up to 6 months
Secondary	Intracerebal haemorrhage	Occurrence of intracerebral haemorrhage related to aneurysm treatment	up to 6 months
Secondary	New neurological deficit	None, motor deficit, sensory deficit, aphasie	up to 6 months
Secondary	Modified Rankin Score	Difference of mRS compared to preoperative status	up to 6 months
Secondary	Glasgow Outcome Scale	From 1 (death) to 5 (low disability)	up to 6 months