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Cranio-spinal Neurosurgical Approaches

Cranio-spinal Neurosurgical Approaches: Qualitative and Quantitative Analysis and Validation of New Minimally Invasive Methods on Cadaveric Anatomical Models.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07287462
Acronym
Neuro_SURGEM
Enrollment
35
Registered
2025-12-17
Start date
2025-12-30
Completion date
2028-07-30
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cadaveric Training, Minimally Invasive Techniques, Neurosurgical Procedures

Keywords

Cranio-spinal surgery, Neurosurgery, Minimally invasive techniques, Surgical validation, Anatomical models, Cadaveric dissection, Neuroanatomy, Surgical training

Brief summary

The goal of this observational study is to learn how different cranio-spinal surgical approaches work and how much anatomical exposure each technique provides in donated human cadaver specimens. The study also aims to understand anatomical variations and to evaluate new surgical techniques and tools that may improve neurosurgical training and practice. The main questions it aims to answer are: * How much surgical exposure area and volume of work does each cranio-spinal approach allow? * How do anatomical variations influence the effectiveness and feasibility of different approaches? Researchers will also compare results obtained using different surgical visualization methods (such as the surgical microscope approach or macroscopic evaluation) to see if any method improves visibility or operative efficiency. Cadaveric specimens will undergo: * Step-by-step cranio-spinal surgical approaches performed by trained neurosurgeons. * Quantitative measurements of exposed anatomical areas using imaging software (BrainChop). * Assessment of operative time, perceived difficulty by surgeons, and visibility of target anatomical structures. * Testing of new surgical instruments or techniques when applicable, without involving any drugs or medical devices. This study follows Italian regulations on post-mortem body donation for scientific research (Law No. 10/2020) and is conducted at a single research center recognized as an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico-Scientific Institute for Hospitalization and Care).

Detailed description

This observational, monocentric, preclinical study. The main objective of this study is to conduct a systematic and quantitative preclinical analysis of multiple cranio-spinal surgical approaches, using both macroscopic and microscopic evaluation. The study evaluates multiple surgical corridors to the cranial and spinal regions and involves detailed measurement of the volume of work and exposed anatomical area attainable with each approach. Additional technical objectives include the analysis of anatomical variations that may influence surgical execution, and the validation of new surgical techniques and instruments in a controlled laboratory environment. All dissections will be carried out on cadaveric specimens voluntarily donated according to Italian legislation on post-mortem body donation (Law No. 10/2020). Procedures will be performed by trained neurosurgeons using standard microsurgical techniques. Quantitative measurements of exposure areas and operative volumes will be obtained using dedicated imaging software, including BrainChop. The study also incorporates structured evaluations of technical difficulty and surgeon experience. After completing each approach, operating surgeons will provide standardized ratings of perceived difficulty, visibility of target structures, and usability of any new surgical tools or techniques tested. These assessments contribute to the systematic validation of surgical methods and instrumentation in the preclinical setting. In addition, the study supports surgical education by integrating structured dissection sessions. Participants (surgeons or trainees) will complete pre- and post-training assessments to evaluate procedural understanding, anatomical knowledge, and perceived skill acquisition. The study will enroll 35 cadaveric specimens over a three-year period. No drugs or implantable medical devices will be used. All specimens will be stored and handled according to institutional anatomical laboratory standards. The statistical analysis plan includes descriptive and comparative analyses. Quantitative variables-such as exposure area, volume of work, and operative time-will be summarized as mean ± standard deviation (SD). Qualitative variables-such as visibility scores or difficulty ratings-will be reported as absolute and relative frequencies. For pre- and post-training comparisons, the paired t-test or Wilcoxon signed-rank test will be applied depending on data distribution. Comparisons of operative time or exposure metrics across techniques will be performed using Analysis of Variance (ANOVA) or the Kruskal-Wallis test. Statistical significance will be defined as p \< 0.05. All analyses will be conducted using Stata statistical software (StataCorp LLC, College Station, TX, USA).

Interventions

PROCEDUREStandardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.

This intervention consists of performing standardized cranio-spinal neurosurgical approaches on donated human cadaveric specimens to evaluate surgical exposure, operative feasibility, and anatomical variation in a preclinical setting. The procedures use both macroscopic and microscopic visualization systems. uantitative measurements of exposure area and operative workspace are obtained through dedicated imaging and navigation-based software. The intervention also allows controlled testing of new surgical tools or techniques, with surgeon-reported assessments of difficulty, visibility, and usability. In addition, hands-on dissection sessions are incorporated to support structured surgical training and technical skill development.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cadaveric specimens from individuals who provided informed consent for post-mortem donation of their body or tissues for scientific research. * Specimens that meet all legal requirements for anatomical donation under Italian Law No. 10/2020 and Presidential Decree (DPR) No. 47/2023. * Specimens that are available for the full duration of the study and suitable for performing multiple cranio-spinal surgical approaches.

Exclusion criteria

* Specimens that do not meet the legal or ethical requirements for anatomical donation as defined by Italian regulations. * Cadavers with major anatomical deformities, advanced tissue degradation, or pathological conditions that would interfere with surgical dissection or measurement accuracy. * Specimens lacking adequate documentation or verified donor consent for post-mortem donation.

Design outcomes

Primary

MeasureTime frameDescription
Quantification of Work Volume and Exposed Area in Cranio-Spinal Surgical ApproachesMeasurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.Work volume represents the three-dimensional operative space created by each cranio-spinal surgical approach. Quantification will be performed using BrainChop imaging software on standardized CT scans. Segmentation will follow predefined protocols to ensure reproducibility. Higher values indicate a larger and more accessible operative corridor. Unit of Measure: cubic millimeters (mm³).
Exposed Anatomical Surface Area Obtained by Each Surgical ApproachMeasurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.Exposed Anatomical Surface Area Obtained by Each Surgical Approach Description: Exposed area corresponds to the two-dimensional anatomical surface revealed by each surgical approach. Measurements will be obtained from CT-based reconstructions using the same standardized segmentation workflow. Higher surface values reflect wider surgical exposure. Unit of Measure: square millimeter

Contacts

Primary ContactFrancesco Doglietto, MD, PhD
francesco.doglietto@policlinicogemelli.it+3906 3015.4120
Backup ContactMartina Offi, MD
martina.offi@guest.policlinicogemelli.it+3906 3015.4120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026