Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms

Recruiting

• Conditions: Aneurysm; Aneurysm Cerebral; Aneurysm, Brain; Aneurysm, Intracranial; Aneurysm of Cerebral Artery

• Registration Number: NCT05029947
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-12-31
• Study First Submitted: 2021-08-29
• Study First Submitted QC: 2021-08-29
• Study First Posted: 2021-09-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-22
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete occlusion of aneurysm	up to 6 months	Aneurysm remnant in CT scan or angiography
Retreatment of aneurysm	up to 6 months	Necessity of retreatment in endovascular or microsurgical technique
Mortality	up to 6 months	Death of the patient

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany