NCT06493435尚未招募不适用
Evaluation du Protocole de PBM du Service de Chirurgie gynécologique du CHU d'Angers: étude Periope 2
University Hospital, Angers0 个研究点目标入组 160 人开始时间: 2024年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- rate of immediate pre operative anemia
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •being hospitalised for planned hysterectomy or cancer related ovariectomy
排除标准
- •less than 18 years
- •non french speaker
- •being under a legal individual protection measure
- •not being able to consent
- •being opposed to data collection
结局指标
主要结局
rate of immediate pre operative anemia
时间窗: at 2 and 8 months after establishment of PBM protocol
preoperative Hb\<13g/dL
次要结局
- early post operative recovery(at 2 and 8 months after establishment of PBM protocol)
- delayed post operative recovery(at 2 and 8 months after establishment of PBM protocol)
- adhesion to PBM protocol (rate of anemia)(at 2 and 8 months after establishment of PBM protocol)
- efficiency of PBM protocol (iron treatment rate)(at 2 and 8 months after establishment of PBM protocol)
- efficiency of PBM protocol (rate of screening anemia and the rate of preoperative anemia )(at 2 and 8 months after establishment of PBM protocol)
- immediat effect of surgery on anemia incidence(at 2 and 8 months after establishment of PBM protocol)
- adhesion to PBM protocol (missing datas)(at 2 and 8 months after establishment of PBM protocol)
- efficiency of PBM protocol (perioperative transfusion rate)(at 2 and 8 months after establishment of PBM protocol)
- efficiency of PBM protocol (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)(at 2 and 8 months after establishment of PBM protocol)
- efficiency of PBM protocol (preoperative anemia rate)(at 2 and 8 months after establishment of PBM protocol)
- efficiency of PBM protocol (Hb level between anesthetic evaluation and pre anesthetic visit)(at 2 and 8 months after establishment of PBM protocol)
- efficiency of PBM protocol (difference of hemoglobin level after iron treatment)(at 2 and 8 months after establishment of PBM protocol)
- effectiveness of iron treatment(at 2 and 8 months after establishment of PBM protocol)
- rate of preoperative anemia that need to be treated diagnosed during anesthetic consultation(at 2 and 8 months after establishment of PBM protocol)
- rate of Hemoglobin dosage available during anesthetic evaluation(at 2 and 8 months after establishment of PBM protocol)
- rate of preoperative iron deficiency that need to be treated diagnosed during anesthetic consultation(at 2 and 8 months after establishment of PBM protocol)
- adequacy between diagnosed iron deficiency anemia and treatment(at 2 and 8 months after establishment of PBM protocol)
- delayed effect of surgery on anemia incidence(at 2 and 8 months after establishment of PBM protocol)
研究者
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