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Not yet recruiting NCT06493435

Efficiency of Patient Blood Management Protocol in Gynecological Surgery Department (PERIOPESGYNECO)

Observational Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Anemia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • rate of immediate pre operative anemia [Time frame: at 2 and 8 months after establishment of PBM protocol]
Secondary outcome measures (12)
  • rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • rate of Hemoglobin dosage available during anesthetic evaluation [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • adequacy between diagnosed iron deficiency anemia and treatment [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • effectiveness of iron treatment [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • immediat effect of surgery on anemia incidence [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • delayed effect of surgery on anemia incidence [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • early post operative recovery [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • delayed post operative recovery [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • adhesion to PBM protocol (rate of anemia) [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • efficiency of PBM protocol (iron treatment rate) [Time frame: at 2 and 8 months after establishment of PBM protocol]
  • adhesion to PBM protocol (missing datas) [Time frame: at 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06493435 · 24_0207

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗