Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07153224

The MICROSCOPE Project

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST GOM Niguarda

Milan, Lombardy, 20162, Italy

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]

Behavioral

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.

Primary outcomes

  1. Burnout: Emotional Exhaustion

    Time frame: Baseline, Perioperative, 3 months, 6 months

    Maximun score 48. High scores relate to higher Emotional Exhaustion, contributing to higher burnout

Secondary outcomes

  1. Burnout: Depersonalization

    Time frame: Baseline, Perioperative, 3 months, 6 months

    Depersonalizzation (DP) considering the treshold of 10 points from the Maslach Burnout Inventory

  2. Psychological resilience

    Time frame: Baseline, Perioperative, 3 months, and 6 months

    Maximum score 40. High scores relate to higher resilience, contributing to potentially higher well-being

  3. Perceived Surgical Performance

    Time frame: 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

  4. Perceived Surgical Performance by the assistant

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Piero Bernardo Cioffi, MD

CONTACT

[email protected]

+393386032519

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

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

Acronym: MICROSCOPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.