About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of both sexes, aged ≥18 years.
Adenocarcinoma of the right, left, sigmoid and recto-sigmoid junction that have cT3 or cT4a/b according to the eighth TNM edition of the American Joint Committee on Cancer (AJCC). Pre-treatment diagnosis by imaging (CT) test.
Lymph node extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pretreatment diagnosis by imaging (CT) test.
Patients who access and sign informed consent for the surgical intervention.
Disqualifiers
Suspected carcinomatosis on preoperative CT or intraoperative finding
Suspected distant metastasis on preoperative CT or intraoperative finding
Patients with tumors with infiltration considered to be unresectable (pre-surgical or intraoperatively), since the anatomical-pathological analysis will not be available.
Trial design
Parallel
Treatments tested in this trial
3D reconstruction
Diagnostic test3D 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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.
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).
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).
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.
Locations
Sponsors and contacts
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Fundació d'investigació Sanitària de les Illes Balears
Lead sponsor
Asociacion Española de Coloproctologia
Collaborator
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