NCT03772821

Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery

Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Bifurcation Surgery

Interventions

Type	Name	Description
OTHER	Data collection	Between D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data
OTHER	Incision/scar measurement	Between D0 and D90

Timeline

• Start date: 2019-01-08
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2018-12-11
• Last updated: 2024-07-01

Locations

7 sites across 1 country: France