Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Evaluation of the QoR-15 score D1
研究概览
简要总结
It is an observational study, prospective in order to assess the impact of the implementation of an early rehabilitation program on post-operative recovery. this is measured by the qOR15 questionnaire in patients operated on for a programmed hysterectomy, it takes place in the gynecology department of the CHR Metz-Thionville hospital.
详细描述
This program implemented will comply with HAS recommendations. The only change in management for patients participating in the study is the completion of the self-questionnaire QOR-15 on D-1 (the day before surgery), D0 (the day of the surgery) and D1 (the day after the surgery).
It is planned to include 74 patients before the implementation of the early rehabilitation protocol and 74 patients after the implementation of the early rehabilitation protocol. The total duration of inclusion is established at 18 months.
The measures applied should improve the patient's well-being and accelerate his return to normal life and therefore reduce the length of his stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Indication of a scheduled hysterectomy
- •Presence of a utero-ovarian affection, deemed resectable and requiring a regulated hysterectomy (outside the context of the emergency) associated or not with pelvic or lumbar-aortic dissection.
- •classified ASA 1 to 3
- •informed about the principles of improved rehabilitation by the surgeon and the anesthesiologist + written document (accessible on the site www.grace-asso.fr).
- •able to return home after discharge from the hospital, having a telephone and being able to contact their doctor or the service if necessary or transferred to a convalescent home at their request.
排除标准
- •Patients included in another study
- •Refusal to use data by the patient
- •Inability to respond to self-questionnaires due to cognitive impairment, difficulties in reading or understanding the French language
- •Patients included in another study
- •Patients with severe or unbalanced associated conditions
结局指标
主要结局
Evaluation of the QoR-15 score D1
时间窗: day 1
The QoR score 15 is a self-questionnaire of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support. These 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions. A variation of 8 points is considered significant.
次要结局
- Overall duration of the hospital stay day of discharge from hospital(Up to 30 days)
- Duration of fasting pre and post-operative(Up to 30 days)
- Overall duration of the hospital stay D-1(One day before surgery)
- Post-operative nausea / vomiting Day 0(Day of surgery)
- Post-operative nausea / vomiting day of hospital discharge(Up to 30 days)
- Time to return gastrointestinal function(Up to 30 days)
- Post-operative nausea / vomiting D+1(One day after surgery)
- Intraoperative maximum Visual Analog Scale (VAS) on day 0(day 0)
- Intraoperative maximum visual analog scale (VAS) on day 1(One day after surgery)
- Intraoperative maximum visual analog scale (VAS) on day of discharge from hospital(Up to 30 days)
- Enhancement of gastrointestinal motility on day 1(One day after surgery)
- Time before first standing(Up to 30 days)
- Evaluation of the QoR-15 score D-1(Day -1)
- Rate of laparotomy(day 0)
- Enhancement of gastrointestinal motility on Day 0(day 0)
- Evaluation of the QoR-15 score D0(Day 0)
- Enhancement of gastrointestinal motility on the day of discharge from the hospital(Up to 30 days)
- Presence of a urinary catheter or drain in postoperative(day 0)
- Mobility on day 1(One day after surgery)
- Mobility on the day of discharge from the hospital(Up to 30 days)
- occurrence of postoperative complications(day 30)
- Mobility on day 0(day 0)