Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
340 participants
OBSERVATIONAL
2026-03-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Surgeries performed in elective, trauma, or emergency general surgery care
Exclusion Criteria
* Pediatric patients \< 18 years of age
* Patients or surgeons not willing to give their consent to participate
18 Years
ALL
No
Sponsors
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Niguarda Hospital
OTHER
Responsible Party
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Principal Investigators
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Stefano Piero Bernardo Cioffi, MD
Role: PRINCIPAL_INVESTIGATOR
Niguarda Hospital
Locations
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ASST GOM Niguarda
Milan, Lombardy, Italy
Countries
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Central Contacts
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Other Identifiers
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M1
Identifier Type: -
Identifier Source: org_study_id
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