Personalized Treatment Planning in Intracranial Aneurysm Surgeries.

NCT ID: NCT05324605

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

Brief Summary

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Patients who will undergo a intracranial aneurysm (IA) surgery are educated concerning their disease and the surgical procedure.The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Detailed Description

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Patient understanding of their medical condition and treatment satisfaction has gained increasing attention in medicine. As for neurosurgical conditions however, the treatment plan is often difficult for patients to comprehend, with many of them having an inaccurate understanding of the involved anatomy.

Novel technologies therefore may play a role in facilitating patient education. In particular, conventional 2D images makes it sometimes difficult for surgeons to inform their patients about the planned intervention and potential complications. This is why new modalities have been developed for patient information and may have further an impact on resident education to better estimate the treatment plan and potential complication. For the latter, given that intracranial aneurysms (lAs) are increasingly treated via endovascular methods, training opportunities are reduced and understanding of the vascular anatomy can become difficult.

The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Conditions

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Aneurysm Cerebral

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire and use of 3 D tools

Resulting computer tomography(CT) results are transferred to a 3 D projection. Patients will be asked to wear 3 D glasses to be able visualizing the diagnosed vascular pathology. The physician will explain the disaese and treatment. The patient is ask to fill out a questionnaire post 3D consulting

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing elective surgery for non-ruptured IA during the study period will be considered for inclusion. Patients are included if they are at least 18 years old and are able to give informed consent and signed the informed consent form.

Exclusion Criteria

* Patients with ruptured or mycotic IA are not considered. Furthermore, patients elected for IA surgery that are younger than 18 years old, as well as patients who are unable to give informed consent (e.g. neurological impairments) will not be included.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Aarau

OTHER

Sponsor Role collaborator

Prof. Dr. med. Serge Marbacher

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Serge Marbacher

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kantonsspital Aarau AG

Aarau, Canton of Aargau, Switzerland

Site Status

Countries

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Switzerland

References

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Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011 Jul;10(7):626-36. doi: 10.1016/S1474-4422(11)70109-0.

Reference Type BACKGROUND
PMID: 21641282 (View on PubMed)

Andereggen L, Gralla J, Andres RH, Weber S, Schroth G, Beck J, Widmer HR, Reinert M, Raabe A, Peterhans M. Stereolithographic models in the interdisciplinary planning of treatment for complex intracranial aneurysms. Acta Neurochir (Wien). 2016 Sep;158(9):1711-20. doi: 10.1007/s00701-016-2892-3. Epub 2016 Jul 14.

Reference Type BACKGROUND
PMID: 27416860 (View on PubMed)

Kimura T, Morita A, Nishimura K, Aiyama H, Itoh H, Fukaya S, Sora S, Ochiai C. Simulation of and training for cerebral aneurysm clipping with 3-dimensional models. Neurosurgery. 2009 Oct;65(4):719-25; discussion 725-6. doi: 10.1227/01.NEU.0000354350.88899.07.

Reference Type BACKGROUND
PMID: 19834377 (View on PubMed)

Russin J, Babiker H, Ryan J, Rangel-Castilla L, Frakes D, Nakaji P. Computational Fluid Dynamics to Evaluate the Management of a Giant Internal Carotid Artery Aneurysm. World Neurosurg. 2015 Jun;83(6):1057-65. doi: 10.1016/j.wneu.2014.12.038. Epub 2014 Dec 22.

Reference Type BACKGROUND
PMID: 25541083 (View on PubMed)

Slichter SJ. Platelet transfusion therapy. Hematol Oncol Clin North Am. 1990 Feb;4(1):291-311.

Reference Type BACKGROUND
PMID: 2179213 (View on PubMed)

Tanabe J, Ishikawa T, Moroi J, Sakata Y, Hadeishi H. Impact of Right-Sided Aneurysm, Rupture Status, and Size of Aneurysm on Perforator Infarction Following Microsurgical Clipping of Posterior Communicating Artery Aneurysms with a Distal Transsylvian Approach. World Neurosurg. 2018 Mar;111:e905-e911. doi: 10.1016/j.wneu.2018.01.002. Epub 2018 Jan 8.

Reference Type BACKGROUND
PMID: 29325945 (View on PubMed)

Roszelle BN, Babiker MH, Hafner W, Gonzalez LF, Albuquerque FC, Frakes DH. In vitro and in silico study of intracranial stent treatments for cerebral aneurysms: effects on perforating vessel flows. J Neurointerv Surg. 2013 Jul;5(4):354-60. doi: 10.1136/neurintsurg-2012-010322. Epub 2012 Jun 26.

Reference Type BACKGROUND
PMID: 22735859 (View on PubMed)

Other Identifiers

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3 D

Identifier Type: -

Identifier Source: org_study_id

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