肩部手术后护理途径的前瞻性比较多中心研究 (Chirépaule)
Post-operative management of shoulder surgery patients, particularly in terms of pain management and follow-up, can vary from one center to another, influencing clinical outcomes and patient satisfaction. The aim of this study is to compare two approaches to post-operative follow-up in two distinct centers: structured follow-up using the Vivalto-Dom protocol in Paris, and autonomous follow-up through contact with a nurse in Saint-Grégoire. The hypothesis is that these differences in the care pathway will affect pain management, comfort and patient satisfaction. By controlling for operative variability (a single surgeon operating in both centers), the study will identify the most effective follow-up practices for improving post-operative management, with the ultimate aim of optimizing quality of care and reducing post-operative complications.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Philippe Collin, MD
- 电话号码：+33 6 08 91 47 47
- 邮箱：docphcollin@gmail.com
学习地点
-
-
-
Paris、法国、75116
- 招聘中
- Clinique Victor Hugo
-
接触：
- Marion Mandon, PhD
- 电话号码：+33678 27 76 72
- 邮箱：mmandon@vivalto-sante.com
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Saint-Grégoire、法国、35760
- 招聘中
- Centre hospitalier privé Saint-Grégoire
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接触：
- Marion Mandon, PhD
- 电话号码：+33678 27 76 72
- 邮箱：mmandon@vivalto-sante.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient eligible for one of the following 4 types of surgery: Simple non-repair arthroscopic surgery (acromion, calcification), arthroscopic repair surgery (cuff, DAS, bankart), open surgery without prosthesis (ligamentoplasty, bone block), open surgery with prosthesis (inverted prosthesis, anatomic prosthesis, etc.).
Exclusion Criteria:
- Patients with one or more communication disorders.
- Pregnant or breast-feeding patients
- Patients not covered by a social security scheme
- Refusal to participate in research
- Patients unable to understand or give informed consent
- Patients under guardianship, deprived of liberty or under court protection
- Patients with past or present drug addiction
- Patients with neuropathy
- Patients with cognitive disorders
- Patients with chronic illnesses or inflammatory pathologies leading to chronic pain.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：手术后的结构性随访
|
During the pre-operative consultation, the patient receives a prescription for medication (analgesics and anti-inflammatories) for immediate post-operative pain relief. They also receive a "patient information booklet" (see appendix 6). On discharge from surgery, the patient returns home with Vivalto Dom in charge of nursing care and follow-up medication. Vivalto Dom is a homecare structure whose mission is to coordinate the discharge of patients back home, and to ensure continuity of overall care (care and social aspects) between the hospital and the city. |
|
有源比较器：手术后的自由随访
|
The pre-operative and operative course (fasting rules, skin preparation, hospitalization, surgery) is the same as for all routine care patients. The patient is informed before surgery that he or she must make an appointment with a nurse for post-operative care at home; a prescription for medication (analgesics and anti-inflammatories) has been given by the anaesthetist for immediate analgesic treatment, and on discharge from hospital he or she receives another prescription from the surgeon for oral relay treatment. Follow-up at home takes place over 3 days, with a private nurse visiting the patient's home every day. During the follow-up, the nurse performs clinical monitoring of the following items: pulse, blood pressure, temperature, pain, bleeding, monitoring of the surgical wound, transit, nausea and vomiting. The patient is also guided through the medication protocol. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain intensity (VAS)
大体时间：3 days, 6 weeks, 3 months and 6 months after surgery
|
Pain will be measured using VAS (visual analog scale), from 0 ("no pain") to 10 (maximal pain) |
3 days, 6 weeks, 3 months and 6 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
术后并发症
大体时间：手术后3天6周，3个月零6个月
|
手术后3天6周，3个月零6个月
|
|
|
Patient comfort (Likert scale)
大体时间：3 days, 6 weeks, 3 months and 6 months after surgery
|
Patient comfort will be evaluated using a Likert scale for 6 questions. Scale is from 1 (total discomfort) to 5 (total comfort) |
3 days, 6 weeks, 3 months and 6 months after surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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