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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06493435
Acronym
PERIOPESGYNECO
Enrollment
160
Registered
2024-07-10
Start date
2024-06-30
Completion date
2026-12-31
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

anemia, perioperative period, post operative recovery, patient blood management

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.

Interventions

None listed

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
rate of immediate pre operative anemiaat 2 and 8 months after establishment of PBM protocolpreoperative Hb\<13g/dL

Secondary

MeasureTime frameDescription
rate of Hemoglobin dosage available during anesthetic evaluationat 2 and 8 months after establishment of PBM protocolnumber and rate of blood analyses
rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultationat 2 and 8 months after establishment of PBM protocolblood ferritin level \<100 ng/mL
adequacy between diagnosed iron deficiency anemia and treatmentat 2 and 8 months after establishment of PBM protocolrate of iron prescription
effectiveness of iron treatmentat 2 and 8 months after establishment of PBM protocolrate of persistent pre operative anemia after iron treatment
immediat effect of surgery on anemia incidenceat 2 and 8 months after establishment of PBM protocolrate of post operative anemia (Hb\<12g/dL)/ rate of post operative iron treatment
delayed effect of surgery on anemia incidenceat 2 and 8 months after establishment of PBM protocolrate of delayed post operative anemia or iron deficiency
early post operative recoveryat 2 and 8 months after establishment of PBM protocolFQoR 15 on the day of hospital dischage
delayed post operative recoveryat 2 and 8 months after establishment of PBM protocolFQoR 15 at the post operative surgical visit
adhesion to PBM protocol (rate of anemia)at 2 and 8 months after establishment of PBM protocolcomparison of rate of anemia screening
rate of preoperative anemia that need to be treated diagnosed during anesthetic consultationat 2 and 8 months after establishment of PBM protocolHb\<13 g/dL
adhesion to PBM protocol (missing datas)at 2 and 8 months after establishment of PBM protocolcomparison of the rate of missing datas
efficiency of PBM protocol (preoperative anemia rate)at 2 and 8 months after establishment of PBM protocolcomparison of the rate of preoperative anemia
efficiency of PBM protocol (perioperative transfusion rate)at 2 and 8 months after establishment of PBM protocolcomparison of the rate of peri opeartive transfusion
efficiency of PBM protocol (mean of FQoR-15)at 2 and 8 months after establishment of PBM protocolcomparison of the mean of FQoR-15
efficiency of PBM protocol (mean of FQoR-15 between patients with or without preoperative anemia)at 2 and 8 months after establishment of PBM protocolcomparison of FQoR-15 means between patients with or without preoperative anemia
efficiency of PBM protocol (rate of screening anemia and the rate of preoperative anemia )at 2 and 8 months after establishment of PBM protocolcomparison of the rate of screening anemia and the rate of preoperative anemia
efficiency of PBM protocol (Hb level between anesthetic evaluation and pre anesthetic visit)at 2 and 8 months after establishment of PBM protocolcomparison of Hb level between anesthetic evaluation and pre anesthetic visit (paired T test)
efficiency of PBM protocol (difference of hemoglobin level after iron treatment)at 2 and 8 months after establishment of PBM protocolmean difference of hemoglobin level after iron treatment
efficiency of PBM protocol (iron treatment rate)at 2 and 8 months after establishment of PBM protocolcomparison of iron treatment rate

Contacts

Primary ContactSigismond Lasocki
SiLasocki@chu-angers.fr0241353635
Backup ContactElise Houssin
DRCI-Promotion-Interne@chu-angers.fr02 41 35 36 37

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026