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

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

Study Overview

• Status: Recruiting
• Conditions: Aneurysm; Aneurysm, Intracranial; Aneurysm Cerebral; Aneurysm, Brain; Aneurysm of Cerebral Artery
• Intervention / Treatment: Procedure: Microsurgical Clipping of Unruptured Intracranial Aneurysm

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Lasse Dührsen, MD; Email: l.duehrsen@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Lasse Dührsen, MD; Email: l.duehrsen@uke.de
    • Principal Investigator: Lasse Dührsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Lasse Dührsen, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: August 29, 2021
• First Submitted That Met QC Criteria: August 29, 2021
• First Posted (ACTUAL): September 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: BenchmarkUIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No