NCT07153224

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

August 11, 2025

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Burnout: Emotional Exhaustion

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

    Baseline, Perioperative, 3 months, 6 months

Secondary Outcomes (4)

  • Burnout: Depersonalization

    Baseline, Perioperative, 3 months, 6 months

  • Psychological resilience

    Baseline, Perioperative, 3 months, and 6 months

  • Perceived Surgical Performance

    Perioperative

  • Perceived Surgical Performance by the assistant

    Perioperative

Study Arms (1)

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)]

Interventions

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.

Early-career surgeons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST GOM Niguarda

Milan, Lombardy, 20162, Italy

Location

Study Officials

  • Stefano Piero Bernardo Cioffi, MD

    Niguarda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Piero Bernardo Cioffi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

September 3, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After data collection completion, at least 12 months after study start date and for 1 year after then.
Access Criteria
Upon reasonable request to the study principal investigator

Locations