Open Surgery on the Abdominal AortaABORD-3DNCT06063395
Study of the Size of the Operating Fields Depending on the Morphology of the Patients
An observational study of Open Surgery on the Abdominal Aorta, run by Geprovas at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Surgery on the Abdominal Aorta
- What is being tested?
- open surgery on the abdominal aorta by laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2024to 17 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient undergoing open surgery on the abdominal aorta by laparotomy.
Who may be able to join
- 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.
Who cannot join
- Emergency surgery
- Patient without preoperative CT scan
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- open surgery on the abdominal aorta by laparotomy
- Keywords
- Abdominal aorta, Open surgery, Vascular surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open surgery on the abdominal aorta by laparotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing open surgery on the abdominal aorta by laparotomy | Not described Receives: Procedure: open surgery on the abdominal aorta by laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Secondary outcomes (4)
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
Measured: 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
Measured: During surgery
Evaluation of how the algorithm helps to deal with surgery
Evaluation questionnaire for surgeons
Measured: During surgery
Correlate results with surgical complications
Intra-hospital complications
Measured: During the procedure until patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start15 May 2024
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Surgery on the Abdominal AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geprovas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nabil Chakfe, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063395
- Sponsor's protocol ID
- 2023-A01613-42
- Acronym
- ABORD-3D
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Size of the Operating Fields Depending on the Morphology of the Patients
- ClinicalTrials.gov ID
- NCT06063395
- Acronym / sponsor ID
- ABORD-3D / 2023-A01613-42
- Conditions
- Open Surgery on the Abdominal Aorta
- Keywords
- Abdominal aorta, Open surgery, Vascular surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GeprovasResearch network
- Study start
- 15 May 2024 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing open surgery on the abdominal aorta by laparotomy | – | Procedure: open surgery on the abdominal aorta by laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing open surgery on the abdominal aorta by laparotomy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Emergency surgery
- Patient without preoperative CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open surgery on the abdominal aorta by laparotomyLaparotomy 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. | Procedure or surgery | Patient undergoing open surgery on the abdominal aorta by laparotomy |
Primary outcome
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.
4 secondary outcomes
Find a correlation between work volume and BMI du patient.
Time frame: During surgery
Validate the algorithm for predicting the volume of work in abdominal aortic abdominal aortic surgery.
Time frame: During surgery
Evaluation of how the algorithm helps to deal with surgery
Time frame: During surgery
Correlate results with surgical complications
Time frame: During the procedure until patient discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabil Chakfe principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Surgery on the Abdominal Aorta, run by Geprovas at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.