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| Name | Class |
|---|---|
| Asociacion Española de Coloproctologia | OTHER |
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The aim of this study is to assess the usefulness of a mathematical model of three-dimensional image process and reconstuction (3D-IPR) as a surgical planner in locally advanced colon cancer. In addition to comparing the diagnostic accuracy of this planner with that of the CT regarding the infiltration of neighbouring structures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No 3D reconstruction group (Group A) | No Intervention | Group of patients in which 3D reconstruction is not going to be performed before surgery | |
| 3D Reconstruction Group (Group B) | Experimental | Group of patients in which 3D reconstruction is going to be done before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D reconstruction | Diagnostic Test | 3D mathematical reconstruction from the extension CT, which is performed on all patients with colon neoplasms, to assess the location of the primary colon tumor and possible infiltration of neighboring/retroperitoneal structures. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Proportion of patients achieving R0 resection (defined as microscopically margin-negative resection) following surgical planning with three-dimensional image post-processing reconstruction (3D-IPR) in patients with threatened surgical margins (TSM) in locally advanced colon cancer (LACC) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of perioperative complications (Clavien-Dindo classification) | Proportion of patients experiencing perioperative complications within 30 days after surgery, classified according to the Clavien-Dindo grading system, following surgical planning with three-dimensional image post-processing reconstruction in patients with locally advanced colon cancer. | Within 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Jeri-McFarlane, MD, PhD | Contact | +34871205000 | sebastian.jeri@ssib.es |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36709852 | Background | Garcia-Granero A, Jeri Mc-Farlane S, Gamundi Cuesta M, Gonzalez-Argente FX. Application of 3D-reconstruction and artificial intelligence for complete mesocolic excision and D3 lymphadenectomy in colon cancer. Cir Esp (Engl Ed). 2023 May;101(5):359-368. doi: 10.1016/j.cireng.2023.01.006. Epub 2023 Jan 26. | |
| 36974360 | Background |
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De-identified individual participant data (IPD) from this study, including clinical variables and imaging-derived measurements, will be made available to qualified researchers. IPD will not be directly posted on ClinicalTrials.gov, but may be requested from the corresponding author. A methodologically sound research proposal must be submitted and approved by the study steering committee. Data sharing will comply with all applicable data protection regulations. Once data are available, a link to the repository will be provided in the Available IPD/Information field of the record.
Researchers with a methodologically sound proposal can request access by contacting the corresponding author. Requests will be reviewed and approved by the study steering committee. Access will be granted after agreement to terms regarding confidentiality, ethical use, and compliance with data protection regulations.
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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 | Mar 29, 2026 | Mar 29, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| Rate of minimally invasive surgical approach | Proportion of patients undergoing a minimally invasive surgical approach (laparoscopic or robotic) following preoperative planning with three-dimensional image post-processing reconstruction (3D-IPR) in patients with locally advanced colon cancer (LACC). | Within 8 Weeks |
| Conversion to open surgery | Proportion of patients requiring conversion from minimally invasive to open surgery during procedures planned with three-dimensional image post-processing reconstruction (3D-IPR) in patients with locally advanced colon cancer (LACC). | 8 Weeks |
| Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity) | Sensitivity and specificity of three-dimensional image post-processing reconstruction (3D-IPR) compared with conventional CT radiological reports for the detection of adjacent organ infiltration in patients with locally advanced colon cancer (LACC), using intraoperative findings and/or histopathological assessment as the reference standard. | Within 8 Weeks |
| Overall survival (OS) | Overall survival, defined as the time from surgery to death from any cause, in patients with locally advanced colon cancer (LACC) undergoing surgical planning with three-dimensional image post-processing reconstruction (3D-IPR). | Up to 5 years |
| Rate of locoregional and distant recurrence | Proportion of patients experiencing locoregional or distant recurrence within 5 years after surgery, confirmed by imaging studies (CT, MRI, or PET-CT) or histopathology, in patients with locally advanced colon cancer (LACC) undergoing surgical planning with three-dimensional image post-processing reconstruction (3D-IPR). | Up to 5 years |
| Jeri-McFarlane S, Garcia-Granero A, Ochogavia-Segui A, Pellino G, Oseira-Reigosa A, Gil-Catalan A, Brogi L, Ginard-Vicens D, Gamundi-Cuesta M, Gonzalez-Argente FX. Three-dimensional modelling as a novel interactive tool for preoperative planning for complex perianal fistulas in Crohn's disease. Colorectal Dis. 2023 Jun;25(6):1279-1284. doi: 10.1111/codi.16539. Epub 2023 Mar 27. |
| 39699719 | Background | Garcia-Granero A, Jeri-McFarlane S, Torres-Mari N, Brogi L, Ferra-Canet M, Navarro Zoroa MA, Gamundi-Cuesta M, Gonzalez-Argente FX. 3D-reconstruction printed models and virtual reality improve teaching in oncological colorectal surgery. Tech Coloproctol. 2024 Dec 19;29(1):24. doi: 10.1007/s10151-024-03074-3. |
| 40783150 | Background | Garcia-Granero A, Jeri-McFarlane S, Ochogavia A, Gamundi-Cuesta M, Garcia-Granero E, Gonzalez-Argente FX. 3D reconstructions in rectal cancer. New tools for better diagnosis and surgical planning. Cir Esp (Engl Ed). 2025 Sep;103(9):800198. doi: 10.1016/j.cireng.2025.800198. Epub 2025 Aug 7. |
| 40365997 | Background | Jeri-McFarlane S, Garcia-Granero A, Ochogavia-Segui A, Ginard-Vicens D, Brogi L, Ferra-Canet M, Gamundi-Cuesta M, Gonzalez-Argente FX. 3D-reconstruction printed models could enhance understanding of Crohn's disease complex perianal fistulas? ANZ J Surg. 2025 Nov;95(11):2359-2366. doi: 10.1111/ans.70140. Epub 2025 May 14. |
| 41483146 | Background | Torres-Mari N, Garcia-Fuster AG, Jeri-McFarlane S, Ochogavia-Segui A, Diaz-Ferrando J, Gomez-Gomes G, Gamundi-Cuesta M, Gonzalez-Argente FX. Anatomy-guided computational framework for classifying vascular ligation and lymphadenectomy in oncologic sigmoidectomy: toward AI-supported surgical auditing. Int J Colorectal Dis. 2026 Jan 3;41(1):12. doi: 10.1007/s00384-025-05046-x. |
| 39808969 | Background | Jeri-McFarlane S, Garcia-Granero A, Martinez-Ortega MA, Amengual-Antich I, Robayo AR, Gamundi-Cuesta M, Gonzalez-Argente FX. Tailored-surgery for locally advanced colon cancer based on 3D mathematical reconstruction surgical planner: Observational comparative non-randomized study. Eur J Surg Oncol. 2025 Feb;51(2):109584. doi: 10.1016/j.ejso.2025.109584. Epub 2025 Jan 6. |
| 39375653 | Background | Jeri-McFarlane S, Garcia-Granero A, Pellino G, Torres-Mari N, Ochogavia-Segui A, Rodriguez-Velazquez M, Gamundi-Cuesta M, Gonzalez-Argente FX. Prospective observational non-randomized trial protocol for surgical planner 3D image processing & reconstruction for locally advanced colon cancer. BMC Surg. 2024 Oct 7;24(1):292. doi: 10.1186/s12893-024-02558-1. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |