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正在招募不适用编号 NCT07706244

Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care

报名条件(概要)

  • 年龄:20 Years – 100 Years
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

Taiwan

药品与企业信息

Enhanced Recovery After Surgery (ERAS) pathway其他

A standardized, multidisciplinary perioperative care pathway including standardized preoperative education, nutrition and fasting optimization (shortened fasting time with preoperative carbohydrate drinks), multimodal anesthesia and analgesia (prioritizing non-opioid medications and nerve blocks), and early mobilization (encouraging mobilization within hours postoperatively, early oral intake, and early catheter removal).

Conventional care group其他

Routine perioperative clinical care based on conventional medical orders. It primarily includes conventional routing education, strict fasting from midnight before surgery, and reliance on opioid medications via patient-controlled analgesia (PCA) as the primary method for postoperative pain management. Postoperative mobilization and oral intake are guided later based on patient tolerance and routine medical orders.

研发企业

Buddhist Tzu Chi General Hospital研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

This study investigates whether an Enhanced Recovery After Surgery (ERAS) program can help orthopedic surgery patients feel less anxious before their operation and recover better one year after surgery, compared to conventional (standard) surgical care. Patients who undergo orthopedic surgery, such as joint replacement, often experience significant anxiety before the operation. While ERAS programs, which combine patient education, pain management, and early mobilization, have been shown to shorten hospital stays and reduce complications, less is known about whether they also reduce preoperative anxiety and lead to better long-term outcomes reported by patients themselves. In this prospective cohort study, patients receiving ERAS care will be compared with patients receiving conventional care. Preoperative anxiety will be measured using a validated questionnaire (APAIS). Clinical recovery during hospitalization, including length of stay, pain scores, and opioid use, will also be recorded. Patients will then be followed for one year to assess their quality of life (EQ-5D-5L) and their own impression of overall improvement (Patient Global Impression of Change). The goal of this study is to determine whether ERAS not only improves short-term surgical recovery, but also reduces preoperative anxiety and leads to better long-term, patient-centered outcomes.

适应症

Preoperative AnxietyOrthopedic SurgeryPatient Reported Outcome (PRO)

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人(申办方/研究总部)

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
ClinicalTrials.gov Identifier: NCT07706244
Sponsor: Buddhist Tzu Chi General Hospital
Investigational product: Enhanced Recovery After Surgery (ERAS) pathway, Conventional care group

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
试验编号:NCT07706244
申办方:Buddhist Tzu Chi General Hospital
研究药物:Enhanced Recovery After Surgery (ERAS) pathway、Conventional care group

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 113330117@gms.tcu.edu.tw

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面