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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:
Cadaveric specimens will undergo:
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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Doglietto, MD, PhD | Contact | +3906 3015.4120 | francesco.doglietto@policlinicogemelli.it | |
| Martina Offi, MD | Contact | +3906 3015.4120 | martina.offi@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Doglietto | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28057590 | Background | 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. | |
| 30210974 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2025 | Dec 10, 2025 |
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| 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. |
| 28254536 | Background | 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. |
| 30592348 | 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. |
| 17110074 | Background | Ebner FH, Koerbel A, Kirschniak A, Roser F, Kaminsky J, Tatagiba M. Endoscope-assisted retrosigmoid intradural suprameatal approach to the middle fossa: anatomical and surgical considerations. Eur J Surg Oncol. 2007 Feb;33(1):109-13. doi: 10.1016/j.ejso.2006.09.036. Epub 2006 Nov 14. |
| 30610300 | Background | 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. |
| 29354486 | Background | 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. |
| 37763226 | Background | 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. |
| 26052729 | Background | Liu JK, Kshettry VR, Recinos PF, Kamian K, Schlenk RP, Benzel EC. Establishing a surgical skills laboratory and dissection curriculum for neurosurgical residency training. J Neurosurg. 2015 Nov;123(5):1331-8. doi: 10.3171/2014.11.JNS14902. Epub 2015 May 26. |
| 30930320 | Background | 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. |
| 17981192 | Background | 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. |
| 22120404 | Background | 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. |
| 24875190 | Background | 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. |
| 28279760 | Background | 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. |
| 24797429 | Background | Wilkinson TM. Getting consent into perspective. Clin Anat. 2014 Sep;27(6):844-6. doi: 10.1002/ca.22412. Epub 2014 May 2. |
| 24753363 | Background | Jones DG. Using and respecting the dead human body: an anatomist's perspective. Clin Anat. 2014 Sep;27(6):839-43. doi: 10.1002/ca.22405. Epub 2014 Apr 19. |
| 23716492 | Background | Wilkinson TM. Respect for the dead and the ethics of anatomy. Clin Anat. 2014 Apr;27(3):286-90. doi: 10.1002/ca.22263. Epub 2013 May 29. |
| 25727324 | Background | Larner SP, Mcquone B, Schober JM, Loukas M, Terrell M. Perceptions of the living dead: An assessment of knowledge and opinions about whole body donation, its process, and willingness to become cadaveric donors in Pennsylvania. Clin Anat. 2015 May;28(4):442-8. doi: 10.1002/ca.22516. Epub 2015 Feb 26. |
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| 19782876 | Background | McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8. |
| Prot_000.pdf |