Surgical Planning With Patient-specific Pancreaticobiliary Disease With 3D Models

NCT04410640 | Completed DMC

• 1 other identifier: EGE18-6.134
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Three-dimensional (3D) printing has been increasingly used in medical applications with the creation of accurate patient-specific 3D printed models in medical imaging data. However, research on 3D printing in pancreaticobiliary disease is limited with lack of studies on validation of model accuracy. Methods: This is a where general surgery residents, are introduced to 5 distinct hepatopancreatobiliary disease scenarios to generate a perception and required to compare their perception level of these cases with computed tomography (CT), 3D images and 1:1 solid models that the pathology, diverse diagnosis and presurgery diagnosis stages can be investigated.

Conditions

Surgical Injury

Keywords

Graduate medical education; Personalized medicine

Outcome Measures

Primary Outcomes (1)

• compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model

  Our aim is to compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model in 5 different hepatopancreatobiliary disease scenarios to general surgery residents in terms of recognizing the pathology, differential diagnosis and preoperative preparation stages.

  30 minute

Interventions

survey OTHER

Members chosen for this study group are general surgery residents. A quintet with stations composed of normal pancreaticobiliary anatomy, common bile duct tumor, stony cholecystitis, pancreatic head cancer and cholelithiasis was assembled for the study. Each station contained CT, 3D-STL images and 1:1 solid models of cases. Each imaging method associated with the scenarios of the quintet is observed by the residents of the study. An explanatory assessment measure is being used as data collection method where the perception of each imaging method is being evaluated based on their effectiveness in problem identification as well as their efficiency in diverse diagnosis and pre-surgery organization. Participants' perception of residency training was evaluated with a multi-entry survey. The focus of the survey, which was applied by our team was by domains, self determined decision-making, diverse diagnosis, academic scholarship, and scientific appraisal.

Eligibility Criteria

• Age: 24 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Members chosen for this study group are general surgery residents present in Faculty of Medicine, Ege University

You may qualify if:

• normal pancreaticobiliary anatomy case
• common bile duct tumor case,
• acute calculous cholecystitis,
• pancreatic head cancer
• cholelithiasis
• general surgery residents present in Faculty of Medicine, Ege University

You may not qualify if:

• Hepatic disease
• General surgery experts

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Faculty of Medicine

Izmir, Bornova, TR-35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative Complications

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Muhtar S Ersin, Prof. Dr

  Faculty of Medicine, Ege University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr, Senior investigator

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: June 1, 2020
• Study Start: July 10, 2019
• Primary Completion: November 10, 2019
• Study Completion: January 10, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)