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Not yet recruiting NCT07153224

The MICROSCOPE Project

Conditions: Early Career Surgeons Mental Wellbeing Patients Outcomes Mentorship Surgical Coaching Intra-operative Consultation

Sponsor: Niguarda Hospital

trial.available_in: БГ
Overview
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
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.
Who can participate
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
Interventions
Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]
BEHAVIORAL
Locations 1
Italy (1)
ASST GOM Niguarda
Milan , Lombardy
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
31.12.2027
Registry ID
NCT07153224
Source
clinicaltrials.gov
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