The MICROSCOPE Project

Not yet recruiting

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

• Registration Number: NCT07153224
• Lead Sponsor: Niguarda Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-25
• Status Verified: 2025-09
• Study First Posted: 2025-09-03
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-11
• Study Start: 2026-03-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Burnout: Emotional Exhaustion	Baseline, Perioperative, 3 months, 6 months	Maximun score 48. High scores relate to higher Emotional Exhaustion, contributing to higher burnout

Secondary Outcome Measures

Name	Time	Method
Perceived Surgical Performance by the assistant	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
Burnout: Depersonalization	Baseline, Perioperative, 3 months, 6 months	Depersonalizzation (DP) considering the treshold of 10 points from the Maslach Burnout Inventory
Psychological resilience	Baseline, Perioperative, 3 months, and 6 months	Maximum score 40. High scores relate to higher resilience, contributing to potentially higher well-being
Perceived Surgical Performance	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

Trial Locations

Locations (1)

ASST GOM Niguarda; 🇮🇹 Milan, Lombardy, Italy