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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Elise Houssin; Phone Number: +33 02 41 35 36 37; Email: DRCI-Promotion-Interne@chu-angers.fr
• Study Contact Backup: Name: Sigismond Lasocki; Phone Number: +33 0241353635; Email: SiLasocki@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patient with planned surgery of hyterectomy or cancer related ovariectomy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of immediate pre operative anemia	preoperative Hb<13g/dL	at 2 and 8 months after establishment of PBM protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation	Hb<13 g/dL	at 2 and 8 months after establishment of PBM protocol
rate of Hemoglobin dosage available during anesthetic evaluation	number and rate of blood analyses	at 2 and 8 months after establishment of PBM protocol
rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation	blood ferritin level <100 ng/mL	at 2 and 8 months after establishment of PBM protocol
adequacy between diagnosed iron deficiency anemia and treatment	rate of iron prescription	at 2 and 8 months after establishment of PBM protocol
effectiveness of iron treatment	rate of persistent pre operative anemia after iron treatment	at 2 and 8 months after establishment of PBM protocol
immediat effect of surgery on anemia incidence	rate of post operative anemia (Hb<12g/dL)/ rate of post operative iron treatment	at 2 and 8 months after establishment of PBM protocol
delayed effect of surgery on anemia incidence	rate of delayed post operative anemia or iron deficiency	at 2 and 8 months after establishment of PBM protocol
early post operative recovery	FQoR 15 on the day of hospital dischage	at 2 and 8 months after establishment of PBM protocol
delayed post operative recovery	FQoR 15 at the post operative surgical visit	at 2 and 8 months after establishment of PBM protocol
adhesion to PBM protocol (rate of anemia)	comparison of rate of anemia screening	at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (iron treatment rate)	comparison of iron treatment rate	at 2 and 8 months after establishment of PBM protocol
adhesion to PBM protocol (missing datas)	comparison of the rate of missing datas	at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (preoperative anemia rate)	comparison of the rate of preoperative anemia	at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (perioperative transfusion rate)	comparison of the rate of peri opeartive transfusion	at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (mean of FQoR-15)	comparison of the 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)	comparison of FQoR-15 means between patients with or without preoperative anemia	at 2 and 8 months after establishment of PBM protocol
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	at 2 and 8 months after establishment of PBM protocol
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)	at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (difference of hemoglobin level after iron treatment)	mean difference of hemoglobin level after iron treatment	at 2 and 8 months after establishment of PBM protocol

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Sigismond Lasocki, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: anemia; perioperative period; post operative recovery; patient blood management
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 24_0207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No