Clinical trial NCT06493435: Efficiency of Patient Blood Management Protocol in Gynecological Surgery Department (PERIOPESGYNECO)
Official title: Evaluation du Protocole de PBM du Service de Chirurgie gynécologique du CHU d'Angers: étude Periope 2
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anemia
Keywords: anemia
perioperative period
post operative recovery
patient blood management
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-07-10
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with planned surgery of hyterectomy or cancer related ovariectomy

Brief summary: Perioperative anemia is associated with higher risk of red blood cell transfusion, higher rates of morbimortality and lower quality of postoperative recovery. In a context of focussing on higher quality management and improved recovery after surgery, development of Patient Blood management has increased. This study aim to assess PBM protocole in a postoperative context of gynaecological surgery, by comparing indicators at two time periods: 2 and 8 months after establishment of PBM protocol.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* being hospitalised for planned hysterectomy or cancer related ovariectomy

Exclusion Criteria:

* less than 18 years
* non french speaker
* being under a legal individual protection measure
* not being able to consent
* being opposed to data collection

Primary outcomes:
measure: rate of immediate pre operative anemia
timeFrame: at 2 and 8 months after establishment of PBM protocol
Secondary outcomes:
measure: rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: rate of Hemoglobin dosage available during anesthetic evaluation
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: adequacy between diagnosed iron deficiency anemia and treatment
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: effectiveness of iron treatment
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: immediat effect of surgery on anemia incidence
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: delayed effect of surgery on anemia incidence
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: early post operative recovery
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: delayed post operative recovery
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: adhesion to PBM protocol (rate of anemia)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (iron treatment rate)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: adhesion to PBM protocol (missing datas)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (preoperative anemia rate)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (perioperative transfusion rate)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (mean of FQoR-15)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (mean of FQoR-15 between patients with or without preoperative anemia)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (rate of screening anemia and the rate of preoperative anemia )
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (Hb level between anesthetic evaluation and pre anesthetic visit)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: efficiency of PBM protocol (difference of hemoglobin level after iron treatment)
timeFrame: at 2 and 8 months after establishment of PBM protocol
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Angers
name: Sigismond Lasocki
role: PRINCIPAL_INVESTIGATOR
References: