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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06063395
Acronym
ABORD-3D
Enrollment
30
Registered
2023-10-02
Start date
2024-05-15
Completion date
2025-12-17
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Surgery on the Abdominal Aorta

Keywords

Abdominal aorta, Open surgery, Vascular surgery

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.

Interventions

PROCEDUREopen 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.

Sponsors

Geprovas
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
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 surgeryTo 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

MeasureTime frameDescription
Find a correlation between work volume and BMI du patient.During surgeryCoefficient 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 surgeryDifference in cubic centimetres between the volume of work and the predicted one
Evaluation of how the algorithm helps to deal with surgeryDuring surgeryEvaluation questionnaire for surgeons
Correlate results with surgical complicationsDuring the procedure until patient dischargeIntra-hospital complications

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026