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Набор скоро начнётся NCT07153224

The MICROSCOPE Project

— Наблюдательное Early Career Surgeons Mental Wellbeing Patients Outcomes Mentorship

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)].
Кому может быть актуально
Состояния в реестре: Early Career Surgeons, Mental Wellbeing, Patients Outcomes, Mentorship. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Mentorship, Intraoperative Consultation, and Coaching for Resilience and Outcomes in Early-career Surgeons Through Collaborative Peer Environment (MICROSCOPE): a Prospective International Time-bound Project

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое 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 pr

Первичные конечные точки

  • Burnout: Emotional Exhaustion [Срок оценки: Baseline, Perioperative, 3 months, 6 months]
Вторичные конечные точки (4)
  • Burnout: Depersonalization [Срок оценки: Baseline, Perioperative, 3 months, 6 months]
  • Psychological resilience [Срок оценки: Baseline, Perioperative, 3 months, and 6 months]
  • Perceived Surgical Performance [Срок оценки: Perioperative]
  • Perceived Surgical Performance by the assistant [Срок оценки: Perioperative]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • ASST GOM Niguarda — Milan

Идентификаторы

NCT: NCT07153224 · M1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗