Validation of the QoR-15 Score for Assessing Quality of Recovery From Emergency Surgery and Its Association With Long-term Quality of Life.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 375
- 主要终点
- Validity of FQoR-15 questionnaire (48 hours)
研究概览
简要总结
Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management.
In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery.
Different scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery.
All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.
详细描述
Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management. This event is a source of stress, anxiety, pain, and even complications, both minor (nausea, vomiting) and major (such as surgical revision). The perioperative management and the psychological support allocated to each patient will have an impact on the hospitalization experience.
In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery.
Most clinical studies are interested in the reduction of perioperative morbidity and mortality (e.g. decrease in pain intensity measured by a visual analog scale, decrease in the frequency of nausea/vomiting, decrease in the time to remobilization, etc.) but still few of them evaluate in a global way the recovery, in particular in the emergency context.
Currently there is a desire to improve the physical and psychological recovery of our patients. In this context, scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery.
All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old,
- •French speaking,
- •Admitted for any type of urgent surgery (time to surgery < 72 hours) traumaor not
- •Able to answer the questionnaire at hospital admission, alone or with the help of a third party,
- •And agreeing to participate in the study.
排除标准
- •Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,
- •Patients admitted for cardiac surgery or obstetrical surgery (caesarean section),
- •Patients admitted for revision surgery,
- •Patients already included in the study during a previous admission.
结局指标
主要结局
Validity of FQoR-15 questionnaire (48 hours)
时间窗: At 48 hours after surgery
Evaluate the validity of the French version of the QoR-15 to assess immediate postoperative recovery after emergency surgery (at 48 hours)
Validity of FQoR-15 questionnaire (24 hours)
时间窗: At 24 hours after surgery
Evaluate the validity of the French version of the QoR-15 to assess immediate postoperative recovery after emergency surgery (at 24 hours)
次要结局
- Validity of FQoR-15 questionnaire for trauma surgery(At 24 and 48 hours after surgery)
- Validity of FQoR-15 questionnaire for non-traumatic surgery(At 24 and 48 hours after surgery)
- Minimal important difference(At 24 and 48 hours after surgery)
- Quality of life (EQ5D-3L)(3 months after surgery)