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Not yet recruitingNCT07153224MICROSCOPEUpdated Apr 17, 2026

The MICROSCOPE Project

An observational study in Early Career Surgeons, Mental Wellbeing and Patients Outcomes, sponsored by Niguarda Hospital. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Niguarda Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
340
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Early Career Surgeons
  • Mental Wellbeing
  • Patients Outcomes
  • Mentorship
  • Surgical Coaching
  • Intra-operative Consultation
03

In context

Lead sponsor

Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
340 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralPeri-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.

06

What researchers measure

Primary outcomes

  1. Burnout: Emotional Exhaustion

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

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

Secondary outcomes

  1. Burnout: Depersonalization

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

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

  2. Psychological resilience

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

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

  3. 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

    Time frame: Perioperative

  4. 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

    Time frame: Perioperative

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Sep 2027, 15 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2025
First posted
Sep 3, 2025
StartEst.
Jun 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Dec 31, 2027
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07153224
Lead sponsor
Niguarda Hospital
Responsible party
Sponsor
First posted
Sep 3, 2025
Start date
Jun 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 17, 2026

Study contacts

Stefano Piero Bernardo Cioffi, MD
Contact
spbcioffi@gmail.com
+393386032519
Stefano Piero Bernardo Cioffi, MD
principal investigator · Niguarda Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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