Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery (PROFA)

University Hospital Center (CHU) Dijon Bourgogne

Status: Terminated

Conditions: Femoral Bifurcation Surgery

Treatments: Other: Data collection; Other: Incision/scar measurement

Study type: Observational

Funder types: Other

Identifiers

NCT03772821

STEINMETZ 2018

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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