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Not Yet RecruitingNCT07153224

The MICROSCOPE Project

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
340 (estimated)
Sponsor
Niguarda Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPeri-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.

Timeline

Start date
2026-06-01
Primary completion
2027-09-01
Completion
2027-12-31
First posted
2025-09-03
Last updated
2026-04-17

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07153224. Inclusion in this directory is not an endorsement.