Clinical trial NCT03772821: Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery
Official title: Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Femoral Bifurcation Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a surgical approach to the common femoral artery or femoral tripod

Brief 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 (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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)
timeFrame: Between Day 0 and Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Colmar
country: France
facility: CH Colmar
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Mulhouse
country: France
facility: GHR Mulhouse
city: Mâcon
country: France
facility: CH Mâcon
city: Nancy
country: France
facility: CHU Nancy
city: Troyes
country: France
facility: CH Troyes
Study officials:
References: