Study of the Size of the Operating Fields Depending on the Morphology of the Patients (ABORD-3D)

This is a prospective, single-centre, observational clinical study.

Patients who have not expressed their non-opposition, who are of age and who are undergoing open surgery on the abdominal aorta by laparotomy will be included.

The aim is to mathematically model the working volume for abdominal aortic surgery as a function of the preoperative CT scan, the length and orientation of the incision and the morphometric characteristics of the patient, and thus predict the surgical risk.

To meet this objective, the dimensions of the working volume of open abdominal aortic surgery will be measured using a camera to create an algorithm by associating them with the preoperative images and morphometric data of the patient.

Study Overview

• Status: Not yet recruiting
• Conditions: Open Surgery on the Abdominal Aorta
• Intervention / Treatment: Procedure: open surgery on the abdominal aorta by laparotomy

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Maxime BEUTELSTETTER; Phone Number: 0671657194; Email: maxime.beutelstetter@gepromed.com
• Study Contact Backup: Name: Manon Ruhlmann; Phone Number: 0369551682; Email: manon.ruhlmann@gepromed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patient undergoing open surgery on the abdominal aorta by laparotomy.

Description

Inclusion Criteria:

• Patients over 18 years of age
• Patient undergoing open surgery on the abdominal aorta by laparotomy.
• Patient who has been informed of the terms of the study and who has not expressed non-opposition.

Exclusion Criteria:

• Emergency surgery
• Patient without preoperative CT scan

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patient undergoing open surgery on the abdominal aorta by laparotomy

Procedure: open surgery on the abdominal aorta by laparotomy; Laparotomy aortic surgery for the management of an abdominal aortic aneurysm has several distinct stages which will not be altered by the performance of this study. The patient arrives in the operating room and is taken care of by the anesthetic team. The patient is then placed in the correct position for optimal surgical management and a skin cleansing procedure is carried out. A sterile drape is applied and the preoperative checklist in force in the establishment is completed. Initial dissection of the aneurysm and its proximal and distal control is left to the discretion of the principal surgeon. Once the aortic aneurysm has been controlled, the main surgeon places self-static retractors and then prepares to clamp the aorta. The surgeon initiates aortic clamping to create the aorto-biliac or bifemoral bypass. Once the bypass has been created, the operation is completed by closing the surgical approach and the skin incision. The bandage is then applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mathematically model the working volume for abdominal aortic surgery as a function of the preoperative CT scan, the length and orientation of the incision and the morphometric characteristics of the patient, and thus predict surgical risk.	To measure the dimensions of the working volume of an open abdominal aortic surgery using a camera to create an algorithm by associating them with the preoperative images and morphometric data of the patient.	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Find a correlation between work volume and BMI du patient.	Coefficient of determination R² which measures the quality of prediction of work volume as a function of patient BMI	During surgery
Validate the algorithm for predicting the volume of work in abdominal aortic abdominal aortic surgery.	Difference in cubic centimetres between the volume of work and the predicted one	During surgery
Evaluation of how the algorithm helps to deal with surgery	Evaluation questionnaire for surgeons	During surgery
Correlate results with surgical complications	Intra-hospital complications	During the procedure until patient discharge

Collaborators and Investigators

• Sponsor: Geprovas
• Investigators: Principal Investigator: Nabil Chakfe, Hôpitaux universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023-A01613-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No