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

July 4, 2024 updated by: University Hospital, Angers

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
rate of immediate pre operative anemia
Time Frame: at 2 and 8 months after establishment of PBM protocol
preoperative Hb<13g/dL
at 2 and 8 months after establishment of PBM protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
Time Frame: at 2 and 8 months after establishment of PBM protocol
blood ferritin level <100 ng/mL
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
rate of iron prescription
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
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
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
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
rate of delayed post operative anemia or iron deficiency
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
FQoR 15 on the day of hospital dischage
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
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)
Time Frame: at 2 and 8 months after establishment of PBM protocol
comparison of rate of anemia screening
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
comparison of iron treatment rate
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
comparison of the rate of missing datas
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
comparison of the rate of preoperative anemia
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
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)
Time Frame: at 2 and 8 months after establishment of PBM protocol
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)
Time Frame: at 2 and 8 months after establishment of PBM protocol
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 )
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
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
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)
Time Frame: at 2 and 8 months after establishment of PBM protocol
mean difference of hemoglobin level after iron treatment
at 2 and 8 months after establishment of PBM protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Angers

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sigismond LASOCKI, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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