Study Results
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Basic Information
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NOT_YET_RECRUITING
35 participants
OBSERVATIONAL
2025-12-30
2028-07-30
Brief Summary
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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
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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).
Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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.
Standardized 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.
Interventions
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Standardized 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Francesco Doglietto
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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7155
Identifier Type: -
Identifier Source: org_study_id