Cranio-spinal Neurosurgical Approaches

NCT07287462 | Not Yet Recruiting DMC

• 1 other identifier: 7155
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Minimally Invasive Techniques; Neurosurgical Procedures; Cadaveric Training

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Quantification of Work Volume and Exposed Area in Cranio-Spinal Surgical Approaches

  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).

  Measurements 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

  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

  Measurements 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.

Study Arms (1)

Cranio-Spinal Neurosurgical Approaches Using Cadaveric Specimens

This cohort consists of donated human cadaveric specimens used to evaluate a range of cranio-spinal neurosurgical approaches. The group serves as an anatomical model to study surgical exposure, technical feasibility, and anatomical variation in a controlled preclinical setting. Procedures will involve macroscopic and microscopic visualization methods and may include testing of new surgical techniques or instruments. Surgeons performing the dissections will provide structured assessments of technical difficulty, visibility, and usability of the approaches.

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

Interventions

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

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.

Also known as: No other names or identifiers; refers only to standardized cranio-spinal neurosurgical approaches on cadaveric specimens

Cranio-Spinal Neurosurgical Approaches Using Cadaveric Specimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of human cadaveric specimens voluntarily donated for scientific and educational purposes under Italian post-mortem donation regulations. Specimens are obtained through the anatomical donation program of the participating institution and represent a natural range of adult anatomical variability. These cadavers serve as preclinical anatomical models for evaluating cranio-spinal neurosurgical approaches in a controlled laboratory setting. The population provides diverse anatomical characteristics that allow systematic assessment of surgical exposure, feasibility, and technical performance across different surgical corridors.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (21)

• Schreiber A, Ferrari M, Rampinelli V, Doglietto F, Belotti F, Lancini D, Ravanelli M, Rodella LF, Fontanella MM, Nicolai P. Modular Endoscopic Medial Maxillectomies: Quantitative Analysis of Surgical Exposure in a Preclinical Setting. World Neurosurg. 2017 Apr;100:44-55. doi: 10.1016/j.wneu.2016.12.094. Epub 2017 Jan 3.

  PMID: 28057590 BACKGROUND

• Muhanna N, Chan H, Qiu J, Daly M, Khan T, Doglietto F, Kucharczyk W, Goldstein DP, Irish JC, de Almeida JR. Volumetric Analysis of Endoscopic and Maxillary Swing Surgical Approaches for Nasopharyngectomy. J Neurol Surg B Skull Base. 2018 Oct;79(5):466-474. doi: 10.1055/s-0037-1617432. Epub 2018 Jan 19.

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• Jagersberg M, Brodard J, Qiu J, Mansouri A, Doglietto F, Gentili F, Kucharczyk W, Fasel J, Schaller K, Radovanovic I. Quantification of Working Volumes, Exposure, and Target-Specific Maneuverability of the Pterional Craniotomy and Its Minimally Invasive Variants. World Neurosurg. 2017 May;101:710-717.e2. doi: 10.1016/j.wneu.2017.02.011. Epub 2017 Feb 22.

  PMID: 28254536 BACKGROUND

• Ferrari M, Schreiber A, Mattavelli D, Lombardi D, Rampinelli V, Doglietto F, Rodella LF, Nicolai P. Surgical anatomy of the parapharyngeal space: Multiperspective, quantification-based study. Head Neck. 2019 Mar;41(3):642-656. doi: 10.1002/hed.25378. Epub 2018 Dec 28.

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• Doglietto F, Belotti F, Qiu J, Roca E, Radovanovic I, Agur A, Kucharczyk W, Schreiber A, Villaret AB, Nicolai P, Gentili F, Fontanella MM. Endonasal and Transoral Approaches to the Craniovertebral Junction: A Quantitative Anatomical Study. Acta Neurochir Suppl. 2019;125:37-44. doi: 10.1007/978-3-319-62515-7_6.

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• Doglietto F, Qiu J, Ravichandiran M, Radovanovic I, Belotti F, Agur A, Zadeh G, Fontanella MM, Kucharczyk W, Gentili F. Quantitative comparison of cranial approaches in the anatomy laboratory: A neuronavigation based research method. World J Methodol. 2017 Dec 26;7(4):139-147. doi: 10.5662/wjm.v7.i4.139. eCollection 2017 Dec 26.

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• Agosti E, De Maria L, Mattogno PP, Della Pepa GM, D'Onofrio GF, Fiorindi A, Lauretti L, Olivi A, Fontanella MM, Doglietto F. Quantitative Anatomical Studies in Neurosurgery: A Systematic and Critical Review of Research Methods. Life (Basel). 2023 Aug 28;13(9):1822. doi: 10.3390/life13091822.

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• Bohl MA, McBryan S, Spear C, Pais D, Preul MC, Wilhelmi B, Yeskel A, Turner JD, Kakarla UK, Nakaji P. Evaluation of a Novel Surgical Skills Training Course: Are Cadavers Still the Gold Standard for Surgical Skills Training? World Neurosurg. 2019 Jul;127:63-71. doi: 10.1016/j.wneu.2019.03.230. Epub 2019 Mar 28.

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• Berg DA, Milner RE, Fisher CA, Goldberg AJ, Dempsey DT, Grewal H. A cost-effective approach to establishing a surgical skills laboratory. Surgery. 2007 Nov;142(5):712-21. doi: 10.1016/j.surg.2007.05.011.

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• Tschabitscher M, Di Ieva A. Practical guidelines for setting up an endoscopic/skull base cadaver laboratory. World Neurosurg. 2013 Feb;79(2 Suppl):S16.e1-7. doi: 10.1016/j.wneu.2011.02.045. Epub 2011 Nov 7.

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• Kshettry VR, Mullin JP, Schlenk R, Recinos PF, Benzel EC. The role of laboratory dissection training in neurosurgical residency: results of a national survey. World Neurosurg. 2014 Nov;82(5):554-9. doi: 10.1016/j.wneu.2014.05.028. Epub 2014 May 27.

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• Ghosh SK. Paying respect to human cadavers: We owe this to the first teacher in anatomy. Ann Anat. 2017 May;211:129-134. doi: 10.1016/j.aanat.2017.02.004. Epub 2017 Mar 6.

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• Wilkinson TM. Getting consent into perspective. Clin Anat. 2014 Sep;27(6):844-6. doi: 10.1002/ca.22412. Epub 2014 May 2.

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  PMID: 19782876 BACKGROUND

Study Officials

• Francesco Doglietto

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Doglietto, MD, PhD

CONTACT

+3906 3015.4120; francesco.doglietto@policlinicogemelli.it

Martina Offi, MD

CONTACT

+3906 3015.4120; martina.offi@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 17, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share