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Not yet recruitingNCT06493435PERIOPESGYNECOUpdated Jul 10, 2024

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

An observational study in Anemia, sponsored by University Hospital, Angers. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by University Hospital, Angers · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Anemia

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Keywords

  • anemia
  • perioperative period
  • post operative recovery
  • patient blood management
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In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's planned enrollment of 160 is below the median of 200 across 326 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient with planned surgery of hyterectomy or cancer related ovariectomy

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. rate of immediate pre operative anemia

    preoperative Hb\<13g/dL

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

Secondary outcomes

  1. rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation

    Hb\<13 g/dL

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

  2. rate of Hemoglobin dosage available during anesthetic evaluation

    number and rate of blood analyses

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

  3. rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation

    blood ferritin level \<100 ng/mL

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

  4. adequacy between diagnosed iron deficiency anemia and treatment

    rate of iron prescription

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

  5. effectiveness of iron treatment

    rate of persistent pre operative anemia after iron treatment

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

  6. immediat effect of surgery on anemia incidence

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

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

  7. delayed effect of surgery on anemia incidence

    rate of delayed post operative anemia or iron deficiency

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

  8. early post operative recovery

    FQoR 15 on the day of hospital dischage

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

  9. delayed post operative recovery

    FQoR 15 at the post operative surgical visit

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

  10. adhesion to PBM protocol (rate of anemia)

    comparison of rate of anemia screening

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

  11. efficiency of PBM protocol (iron treatment rate)

    comparison of iron treatment rate

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

  12. adhesion to PBM protocol (missing datas)

    comparison of the rate of missing datas

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

  13. efficiency of PBM protocol (preoperative anemia rate)

    comparison of the rate of preoperative anemia

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

  14. efficiency of PBM protocol (perioperative transfusion rate)

    comparison of the rate of peri opeartive transfusion

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

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

    comparison of the mean of FQoR-15

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

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

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

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

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

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

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

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

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

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

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

    mean difference of hemoglobin level after iron treatment

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06493435
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jul 10, 2024
Start date
Jun 30, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 10, 2024

Study contacts

Sigismond Lasocki
Contact
SiLasocki@chu-angers.fr
0241353635 ext. +33
Elise Houssin
Contact
DRCI-Promotion-Interne@chu-angers.fr
02 41 35 36 37 ext. +33
Sigismond Lasocki
principal investigator · University Hospital, Angers

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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