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通过协作同伴环境（显微镜），指导，术中咨询和指导早期外科医生的韧性和成果指导：一个前瞻性的国际计时项目 (MICROSCOPE)

2026年11月9日 更新者：Niguarda Hospital

This multicenter observational prospective study aims to explore the impact of peri-operative support measures (mentorship or coaching or intraoperative consultation) on the mental well-being of early career surgeons. Furthermore sub-analyses will be conducted to explore the impact that surgeons mental wellbeing related to different support measures could have on patients' outcomes

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The MICROSCOPE study is a prospective, international, observational project evaluating the impact of structured perioperative support-mentorship, intraoperative consultation (IOC), and surgical coaching-on the well-being of early-career surgeons and their patients' outcomes.

Early-career surgeons (within 10 years post-training) face high stress, with limited structured support. This study investigates whether professional guidance improves surgeon resilience, reduces burnout, and enhances performance.

The project includes two components:

Surgeon-level study: Participants are observed over 12 months and grouped by support type received. Mental health outcomes are assessed using validated tools (Maslach Burnout Inventory, CD-RISC-10, QoL scale), alongside self- and assistant-rated performance metrics.

Patient-level study: Adult patients operated on by enrolled surgeons during the first 3 months are followed for 90 days. Outcomes include postoperative complications (CCI®, Clavien-Dindo), intraoperative events (Satava), reoperation, readmission, and mortality.

Data are collected via REDCap and analyzed using adjusted mixed-effects models to account for clustering and confounders. The study is investigator-initiated, with no external funding, and adheres to ethical standards including local IRB approval and informed consent.

MICROSCOPE aims to generate real-world evidence on how structured support can improve both surgical care quality and surgeon well-being.

研究类型

观察性的

注册 (估计的)

340

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Stefano Piero Bernardo Cioffi, MD
  • 电话号码：+393386032519
  • 邮箱：spbcioffi@gmail.com

学习地点

  • 意大利
    • Lombardy
      • Milan、Lombardy、意大利、20162
        • ASST GOM Niguarda

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Early career surgeons: graduating in general surgery in the last 10 years Surgeons performing elective general surgery, emergency general surgery and trauma surgery

描述

Inclusion Criteria:

  • Adult patients (≥18 years) treated for abdominal general surgical conditions in the emergency or elective setting or for thoraco-abdominal traumatic diseases. The list of surgical procedures is reported in the Supplementary Material 1
  • Surgeries performed in elective, trauma, or emergency general surgery care

Exclusion Criteria:

  • Patients operated by surgeons who completed general surgery residency more than 10 years before the study start date
  • Pediatric patients < 18 years of age
  • Patients or surgeons not willing to give their consent to participate

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Early-career surgeons

Early career surgeons mental wellbeing status in terms of burnout, resilience and perceived quality of life will be observed exploring the relationship with the peri-operative support measure received (mentorship, intraoperative consultation, surgical coaching or standard practice). Also the outcomes of patients operated on by early career surgeons will be studied. Furthermore potential relationship between perio-operative supporto measures, mental status and outcomes will be explored.
行为的：Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]

Mentorship: Formal (assigned by an institution or via an official program) or informal (personal relationship built during the career pathway) professional guidance relationships that support early-career surgeons in clinical decision-making, technical development, and emotional processing.

Surgical Coaching: Structured, feedback-oriented discussions or sessions aimed at performance enhancement and reflective practice Intraoperative Consultation (IOC): Real-time assistance or second opinions provided by a more experienced surgeon or peers during a surgical procedure Standard practice: the surgeon performs the procedure supported by one or multiple assistants, as per internal hospital protocols and national/local regulations, receiving and providing natural feedback without a structured support system.

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
Burnout: Emotional Exhaustion
大体时间：Baseline, Perioperative, 3 months, 6 months

Maximun score 48. High scores relate to higher Emotional Exhaustion, contributing to higher burnout
Baseline, Perioperative, 3 months, 6 months

次要结果测量

结果测量
措施说明
大体时间
Burnout: Depersonalization
大体时间：Baseline, Perioperative, 3 months, 6 months

Depersonalizzation (DP) considering the treshold of 10 points from the Maslach Burnout Inventory
Baseline, Perioperative, 3 months, 6 months
Psychological resilience
大体时间：Baseline, Perioperative, 3 months, and 6 months

Maximum score 40. High scores relate to higher resilience, contributing to potentially higher well-being
Baseline, Perioperative, 3 months, and 6 months
Perceived Surgical Performance
大体时间：Perioperative

Sefl evaluation by the surgeon using a 5-point Likert scale (1) a procedure that did not go well at all, (2) a procedure that could have gone better, (3) a regular procedure, (4) a successful procedure, (5) a highly successful procedure
Perioperative
Perceived Surgical Performance by the assistant
大体时间：Perioperative

Evaluation by the assistant using a 5-point Likert scale (1) a procedure that did not go well at all, (2) a procedure that could have gone better, (3) a regular procedure, (4) a successful procedure, (5) a highly successful procedure
Perioperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Niguarda Hospital

调查人员

  • 首席研究员：Stefano Piero Bernardo Cioffi, MD、Niguarda Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2025年8月11日

首先提交符合 QC 标准的

2025年8月25日

首次发布 (实际的)

2025年9月3日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • M1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The MICROSCOPE project is committed to ensuring reproducibility and transparency in its research practices. To support this, the following measures will be implemented:

The study protocol and statistical analysis plan (SAP) will be registered and publicly available on Clinicaltrials.gov upon study initiation.

Core study instruments will be documented and shared as supplementary materials in publications where possible.

Statistical code used for primary and secondary outcome analyses will be made available upon reasonable request, subject to data-sharing agreements and institutional approvals.

Deidentified, aggregate-level data may be shared with external collaborators for secondary analysis, conditional on ethical approval and collaborative agreements.

IPD 共享时间框架

After data collection completion, at least 12 months after study start date and for 1 year after then.

IPD 共享访问标准

Upon reasonable request to the study principal investigator

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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