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

Terminated

• Conditions: Femoral Bifurcation Surgery

• Registration Number: NCT03772821
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Study Start: 2019-01-08
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)	Between Day 0 and Day 90

Trial Locations

Locations (7)

CHU Nancy; 🇫🇷 Nancy, France

CH Colmar; 🇫🇷 Colmar, France

CHU Jean Minjoz; 🇫🇷 Besançon, France

CHU Dijon Bourgogne; 🇫🇷 Dijon, France

GHR Mulhouse; 🇫🇷 Mulhouse, France

CH Mâcon; 🇫🇷 Mâcon, France

CH Troyes; 🇫🇷 Troyes, France