AnemiaPERIOPESGYNECONCT06493435
Efficiency of Patient Blood Management Protocol in Gynecological Surgery Department (PERIOPESGYNECO)
An observational study of Anemia, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anemia
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patient with planned surgery of hyterectomy or cancer related ovariectomy
Who may be able to join
- age > 18 years
- being hospitalised for planned hysterectomy or cancer related ovariectomy
Who cannot join
- less than 18 years
- non french speaker
- being under a legal individual protection measure
- not being able to consent
- being opposed to data collection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Anemia
- Keywords
- anemia, perioperative period, post operative recovery, patient blood management
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of immediate pre operative anemia
preoperative Hb<13g/dL
Measured: at 2 and 8 months after establishment of PBM protocol
Secondary outcomes (19)
rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation
Hb<13 g/dL
Measured: at 2 and 8 months after establishment of PBM protocol
rate of Hemoglobin dosage available during anesthetic evaluation
number and rate of blood analyses
Measured: 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
Measured: at 2 and 8 months after establishment of PBM protocol
adequacy between diagnosed iron deficiency anemia and treatment
rate of iron prescription
Measured: at 2 and 8 months after establishment of PBM protocol
effectiveness of iron treatment
rate of persistent pre operative anemia after iron treatment
Measured: 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
Measured: 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
Measured: at 2 and 8 months after establishment of PBM protocol
early post operative recovery
FQoR 15 on the day of hospital dischage
Measured: at 2 and 8 months after establishment of PBM protocol
delayed post operative recovery
FQoR 15 at the post operative surgical visit
Measured: at 2 and 8 months after establishment of PBM protocol
adhesion to PBM protocol (rate of anemia)
comparison of rate of anemia screening
Measured: at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (iron treatment rate)
comparison of iron treatment rate
Measured: at 2 and 8 months after establishment of PBM protocol
adhesion to PBM protocol (missing datas)
comparison of the rate of missing datas
Measured: at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (preoperative anemia rate)
comparison of the rate of preoperative anemia
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: at 2 and 8 months after establishment of PBM protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sigismond Lasocki, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493435
- Sponsor's protocol ID
- 24_0207
- Acronym
- PERIOPESGYNECO
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation du Protocole de PBM du Service de Chirurgie gynécologique du CHU d'Angers: étude Periope 2
- ClinicalTrials.gov ID
- NCT06493435
- Acronym / sponsor ID
- PERIOPESGYNECO / 24_0207
- Conditions
- Anemia
- Keywords
- anemia, perioperative period, post operative recovery, patient blood management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with planned surgery of hyterectomy or cancer related ovariectomy
Key inclusion criteria (2 listed)
- age > 18 years
- being hospitalised for planned hysterectomy or cancer related ovariectomy
Key exclusion criteria (5 listed)
- less than 18 years
- non french speaker
- being under a legal individual protection measure
- not being able to consent
- being opposed to data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of immediate pre operative anemia
Time frame: at 2 and 8 months after establishment of PBM protocol
preoperative Hb<13g/dL
19 secondary outcomes
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
efficiency of PBM protocol (preoperative anemia rate)
Time frame: at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (perioperative transfusion rate)
Time frame: at 2 and 8 months after establishment of PBM protocol
efficiency of PBM protocol (mean of FQoR-15)
Time frame: 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)
Time frame: at 2 and 8 months after establishment of PBM protocol
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
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
efficiency of PBM protocol (difference of hemoglobin level after iron treatment)
Time frame: at 2 and 8 months after establishment of PBM protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sigismond Lasocki principal investigator
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sigismond Lasocki (0241353635 ext. +33, SiLasocki@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of immediate pre operative anemia (time frame: at 2 and 8 months after establishment of PBM protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.