Clinical trial NCT05174702: Assessment of the Ionizing Radiation Received During Percutaneous or Conventional Surgery of Hallux Valgus
Official title: Assessment of the Ionizing Radiation Received by the Patient and the Nursing Staff During Percutaneous or Conventional Surgery of Hallux Valgus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus
Surgery
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be managed in accordance with current practice, the choice of surgical strategy for hallus valgus (percutaneous or conventional) being left to the discretion of the investigators.

Brief summary: To assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.

Detailed description: Prospective, open, comparative, non-randomized, non-interventional, single-center study, focusing on two surgical strategies. Patients will be managed in accordance with current practice, the choice of surgical strategy being left to the discretion of the investigators.

Patients will be informed of the study during a preoperative visit. The data concerning them will be collected on the day of the surgery. No follow-up over time is necessary.

Passive "ring" and "cornea" dosimeters will be worn by healthcare professionals during procedures for patients included in the study. Their data will be collected each month and at the end of the study, and reported secondarily to the number of operations. Several surgeons, dressers and operating assistants will participate in the operations, their data will be aggregated taking into account their function and not individuals.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing percutaneous or conventional hallux valgus surgery;
* Patient capable of understanding the information related to the study, of reading the information leaflet and having expressed his non-opposition to participating in the study.

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty.

Primary outcomes:
measure: Irradiation collected at the end of the operation on the surgeon's active dosimeter
timeFrame: during the time of the surgery
measure: Irradiation collected at the end of the operation on the surgeon's active dosimeter
timeFrame: during the time of the surgery
Secondary outcomes:
measure: Irradiation collected at the end of the operation on the patient's and operating team's
timeFrame: during the time of the surgery
measure: Irradiation collected at the end of the operation on the patient's and operating team's
timeFrame: during the time of the surgery
measure: Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional
timeFrame: 3 months
measure: Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Blomet
Study officials:
References: