Femoral Bifurcation SurgeryPROFANCT03772821
Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery
An observational study of Femoral Bifurcation Surgery, run by Centre Hospitalier Universitaire Dijon at 7 sites in France.
Trial summary
No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Bifurcation Surgery
- What is being tested?
- Data collection and Incision/scar measurement
- How many people
- 163 participants
- Where
- 7 sitesFrance
- Study dates
- 8 Jan 2019to 2 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a surgical approach to the common femoral artery or femoral tripod
Who may be able to join
- Patient who has not opposed participation in the study
- Age > 18 years old
- All patients with an open surgical approach to the common femoral artery and/or femoral bifurcation, uni or bilateral, with or without endovascular or open procedure
Who cannot join
- Patient with homolateral surgery of the femoral triangle which has not yet healed
- Person subject to court-ordered protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding woman
- Adult unable to consent
- Patient who refuses to participate in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Jean Minjoz
Besançon
CH Colmar
Colmar
CHU Dijon Bourgogne
Dijon
CH Mâcon
Mâcon
GHR Mulhouse
Mulhouse
CHU Nancy
Nancy
CH Troyes
Troyes
About this study
Official title: Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study
No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or other), but as of yet, investigators do not have proof of such an effect. The proposed study would follow a prospective, continuous, multicentre cohort of patients to describe the type, frequency and factors that contribute to local and general complications of surgery on the femoral bifurcation. This information is essential in the choice of the best revascularization technique for the femoral artery, which is frequently the site used for interventions in vascular conditions.
Surgeries will be performed in the normal manner. The research will be based on medical data collected during patient management. A measurement of the incision/scar will be taken once the procedure has been performed, either immediately after surgery or after a period of time, during post-operative consultation. Participation in this research will last 3 months from the day of the intervention.
- Conditions
- Femoral Bifurcation Surgery
- Being tested
- Data collection, Incision/scar measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Between D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data
Incision/scar measurementOther
Between D0 and D90
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)
Measured: Between Day 0 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start8 Jan 2019
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Why it stopped: lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Bifurcation SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772821
- Sponsor's protocol ID
- STEINMETZ 2018
- Acronym
- PROFA
- Status last verified
- Jun 2024
- First submitted
- 4 Dec 2018
- Last updated
- 1 Jul 2024
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03772821
- Acronym / sponsor ID
- PROFA / STEINMETZ 2018
- Conditions
- Femoral Bifurcation Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of inclusions
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 11 Dec 2018 (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.
No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or other), but as of yet, investigators do not have proof of such an effect. The proposed study would follow a prospective, continuous, multicentre cohort of patients to describe the type, frequency and factors that contribute to local and general complications of surgery on the femoral bifurcation. This information is essential in the choice of the best revascularization technique for the femoral artery, which is frequently the site used for interventions in vascular conditions.
Surgeries will be performed in the normal manner. The research will be based on medical data collected during patient management. A measurement of the incision/scar will be taken once the procedure has been performed, either immediately after surgery or after a period of time, during post-operative consultation. Participation in this research will last 3 months from the day of the intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a surgical approach to the common femoral artery or femoral tripod
Key inclusion criteria (3 listed)
- Patient who has not opposed participation in the study
- Age > 18 years old
- All patients with an open surgical approach to the common femoral artery and/or femoral bifurcation, uni or bilateral, with or without endovascular or open procedure
Key exclusion criteria (5 listed)
- Patient with homolateral surgery of the femoral triangle which has not yet healed
- Person subject to court-ordered protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding woman
- Adult unable to consent
- Patient who refuses to participate in the study
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 |
|---|---|---|
| Data collectionBetween D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data | Other | – |
| Incision/scar measurementBetween D0 and D90 | Other | – |
Primary outcome
Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)
Time frame: Between Day 0 and Day 90
Results and safety
The study was stopped early (reason given: lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Bifurcation Surgery, run by Centre Hospitalier Universitaire Dijon at 7 sites 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 5 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: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 was stopped early (reason given: lack of inclusions). Results are not available in the source record.
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?
Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele) (time frame: Between Day 0 and Day 90). 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 1 Jul 2024.