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NCT Number: NCT06493435

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. rate of immediate pre operative anemia

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

    preoperative Hb<13g/dL

Secondary outcomes

  1. 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

    Hb<13 g/dL

  2. rate of Hemoglobin dosage available during anesthetic evaluation

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

    number and rate of blood analyses

  3. 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

    blood ferritin level <100 ng/mL

  4. adequacy between diagnosed iron deficiency anemia and treatment

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

    rate of iron prescription

  5. effectiveness of iron treatment

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

    rate of persistent pre operative anemia after iron treatment

  6. immediat effect of surgery on anemia incidence

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

    rate of post operative anemia (Hb<12g/dL)/ rate of post operative iron treatment

  7. delayed effect of surgery on anemia incidence

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

    rate of delayed post operative anemia or iron deficiency

  8. early post operative recovery

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

    FQoR 15 on the day of hospital dischage

  9. delayed post operative recovery

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

    FQoR 15 at the post operative surgical visit

  10. adhesion to PBM protocol (rate of anemia)

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

    comparison of rate of anemia screening

  11. efficiency of PBM protocol (iron treatment rate)

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

    comparison of iron treatment rate

  12. adhesion to PBM protocol (missing datas)

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

    comparison of the rate of missing datas

  13. efficiency of PBM protocol (preoperative anemia rate)

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

    comparison of the rate of preoperative anemia

  14. efficiency of PBM protocol (perioperative transfusion rate)

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

    comparison of the rate of peri opeartive transfusion

  15. efficiency of PBM protocol (mean of FQoR-15)

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

    comparison of the mean of FQoR-15

  16. efficiency of PBM protocol (mean of FQoR-15 between patients with or without preoperative anemia)

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

    comparison of FQoR-15 means between patients with or without preoperative anemia

  17. efficiency of PBM protocol (rate of screening anemia and the rate of preoperative anemia )

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

    comparison of the rate of screening anemia and the rate of preoperative anemia

  18. efficiency of PBM protocol (Hb level between anesthetic evaluation and pre anesthetic visit)

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

    comparison of Hb level between anesthetic evaluation and pre anesthetic visit (paired T test)

  19. efficiency of PBM protocol (difference of hemoglobin level after iron treatment)

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

    mean difference of hemoglobin level after iron treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Houssin

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Sigismond Lasocki

CONTACT

[email protected]

0241353635 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: PERIOPESGYNECO

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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