The MICROSCOPE Project (MICROSCOPE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Wellbeing; Mentorship; Early Career Surgeons; Patients Outcomes; Surgical Coaching; Intra-operative Consultation
• Intervention / Treatment: Behavioral: Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]

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 Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Stefano Piero Bernardo Cioffi, MD; Phone Number: +393386032519; Email: spbcioffi@gmail.com

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20162
      • ASST GOM Niguarda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Early career surgeons: graduating in general surgery in the last 10 years Surgeons performing elective general surgery, emergency general surgery and trauma surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burnout: Emotional Exhaustion	Maximun score 48. High scores relate to higher Emotional Exhaustion, contributing to higher burnout	Baseline, Perioperative, 3 months, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Niguarda Hospital
• Investigators: Principal Investigator: Stefano Piero Bernardo Cioffi, MD, Niguarda hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: August 25, 2025
• First Posted (Actual): September 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: M1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The MICROSCOPE project is committed to ensuring reproducibility and transparency in its research practices. To support this, the following measures will be implemented:

The study protocol and statistical analysis plan (SAP) will be registered and publicly available on Clinicaltrials.gov upon study initiation.

Core study instruments will be documented and shared as supplementary materials in publications where possible.

Statistical code used for primary and secondary outcome analyses will be made available upon reasonable request, subject to data-sharing agreements and institutional approvals.

Deidentified, aggregate-level data may be shared with external collaborators for secondary analysis, conditional on ethical approval and collaborative agreements.

• IPD Sharing Time Frame: After data collection completion, at least 12 months after study start date and for 1 year after then.
• IPD Sharing Access Criteria: Upon reasonable request to the study principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No