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OpenTrials
Completed

NCT Number: NCT06063395

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67000

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 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 outcomes

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

    Time frame: During surgery

    Coefficient of determination R² which measures the quality of prediction of work volume as a function of patient BMI

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

    Time frame: During surgery

    Difference in cubic centimetres between the volume of work and the predicted one

  3. Evaluation of how the algorithm helps to deal with surgery

    Time frame: During surgery

    Evaluation questionnaire for surgeons

  4. Correlate results with surgical complications

    Time frame: During the procedure until patient discharge

    Intra-hospital complications

Sponsors and collaborators

Lead sponsor

Geprovas

Network

Registry information

Acronym: ABORD-3D

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2023
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.