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

Sponsor

Geprovas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06063395

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Surgery on the Abdominal Aorta	Procedure: open surgery on the abdominal aorta by laparotomy

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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. [During surgery]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Geprovas

Investigators

Principal Investigator: Nabil Chakfe, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Geprovas

ClinicalTrials.gov Identifier:

NCT06063395

Other Study ID Numbers:

2023-A01613-42

First Posted:

Oct 2, 2023

Last Update Posted:

Oct 2, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 2, 2023