Study of the Size of the Operating Fields Depending on the Morphology of the Patients

NCT06063395 | Completed

• 1 other identifier: 2023-A01613-42
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Open Surgery on the Abdominal Aorta

Keywords

Abdominal aorta; Open surgery; Vascular surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Find a correlation between work volume and BMI du patient.

  During surgery

• Validate the algorithm for predicting the volume of work in abdominal aortic abdominal aortic surgery.

  During surgery

• Evaluation of how the algorithm helps to deal with surgery

  During surgery

• Correlate results with surgical complications

  During the procedure until patient discharge

Study Arms (1)

Patient undergoing open surgery on the abdominal aorta by laparotomy

Procedure: open surgery on the abdominal aorta by laparotomy

Interventions

open surgery on the abdominal aorta by laparotomy PROCEDURE

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.

Patient undergoing open surgery on the abdominal aorta by laparotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient undergoing open surgery on the abdominal aorta by laparotomy.

You may qualify if:

• 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.

You may not qualify if:

• Emergency surgery
• Patient without preoperative CT scan

Sponsors & Collaborators

• Geprovas: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67000, France

Location

Study Officials

• Nabil Chakfe

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 2, 2023
• Study Start: May 15, 2024
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)