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Clinical Trials/NCT06493435
NCT06493435
Not yet recruiting
Not Applicable

Evaluation du Protocole de PBM du Service de Chirurgie gynécologique du CHU d'Angers: étude Periope 2

University Hospital, Angers0 sites160 target enrollmentJune 30, 2024
ConditionsAnemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia
Sponsor
University Hospital, Angers
Enrollment
160
Primary Endpoint
rate of immediate pre operative anemia
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

rate of immediate pre operative anemia

Time Frame: at 2 and 8 months after establishment of PBM protocol

preoperative Hb\<13g/dL

Secondary Outcomes

  • early post operative recovery(at 2 and 8 months after establishment of PBM protocol)
  • delayed post operative recovery(at 2 and 8 months after establishment of PBM protocol)
  • adhesion to PBM protocol (rate of anemia)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (iron treatment rate)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (rate of screening anemia and the rate of preoperative anemia )(at 2 and 8 months after establishment of PBM protocol)
  • immediat effect of surgery on anemia incidence(at 2 and 8 months after establishment of PBM protocol)
  • adhesion to PBM protocol (missing datas)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (perioperative transfusion rate)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (mean of FQoR-15)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (mean of FQoR-15 between patients with or without preoperative anemia)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (preoperative anemia rate)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (Hb level between anesthetic evaluation and pre anesthetic visit)(at 2 and 8 months after establishment of PBM protocol)
  • efficiency of PBM protocol (difference of hemoglobin level after iron treatment)(at 2 and 8 months after establishment of PBM protocol)
  • effectiveness of iron treatment(at 2 and 8 months after establishment of PBM protocol)
  • rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation(at 2 and 8 months after establishment of PBM protocol)
  • rate of Hemoglobin dosage available during anesthetic evaluation(at 2 and 8 months after establishment of PBM protocol)
  • rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation(at 2 and 8 months after establishment of PBM protocol)
  • adequacy between diagnosed iron deficiency anemia and treatment(at 2 and 8 months after establishment of PBM protocol)
  • delayed effect of surgery on anemia incidence(at 2 and 8 months after establishment of PBM protocol)

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