Early Career SurgeonsMICROSCOPENCT07153224
The MICROSCOPE Project
An observational study of Early Career Surgeons and Mental Wellbeing, run by Niguarda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Career Surgeons, Mental Wellbeing, Patients Outcomes
- What is being tested?
- Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 340 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- Early Career Surgeons, Mental Wellbeing, Patients Outcomes, Mentorship, Surgical Coaching, Intra-operative Consultation
- Being tested
- Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout: Emotional Exhaustion
Maximun score 48. High scores relate to higher Emotional Exhaustion, contributing to higher burnout
Measured: Baseline, Perioperative, 3 months, 6 months
Secondary outcomes (4)
Burnout: Depersonalization
Depersonalizzation (DP) considering the treshold of 10 points from the Maslach Burnout Inventory
Measured: Baseline, Perioperative, 3 months, 6 months
Psychological resilience
Maximum score 40. High scores relate to higher resilience, contributing to potentially higher well-being
Measured: 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
Measured: Perioperative
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
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Career SurgeonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Piero Bernardo Cioffi, MD, Principal investigator, Niguarda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153224
- Sponsor's protocol ID
- M1
- Acronym
- MICROSCOPE
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07153224
- Acronym / sponsor ID
- MICROSCOPE / M1
- Conditions
- Early Career Surgeons, Mental Wellbeing, Patients Outcomes, Mentorship, Surgical Coaching, Intra-operative Consultation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early-career surgeons | – | Behavioral: Peri-operative support measures [mentorship, intraoperative consult, surgical coaching, standard practice (no structured support)]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Early-career surgeons |
Primary outcome
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
4 secondary outcomes
Burnout: Depersonalization
Time frame: Baseline, Perioperative, 3 months, 6 months
Psychological resilience
Time frame: Baseline, Perioperative, 3 months, and 6 months
Perceived Surgical Performance
Time frame: Perioperative
Perceived Surgical Performance by the assistant
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Piero Bernardo Cioffi, MD principal investigator
Niguarda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Career Surgeons and Mental Wellbeing, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Piero Bernardo Cioffi, MD (+393386032519, spbcioffi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout: Emotional Exhaustion (time frame: Baseline, Perioperative, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.