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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-08

Study Completion Date

2020-03-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Femoral Bifurcation Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

Between D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data

Intervention Type OTHER

Incision/scar measurement

Between D0 and D90

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No