Surgical EducationNCT04691206
Operative Curriculum Gallbladder Surgery
A study testing briefing objectives, intraoperative teaching, and debriefing feedback in people with Surgical Education, run by Mayo Clinic at 3 sites in United States.
Trial summary
The goal of this study is to implement and evaluate the need, feasibility and effectiveness of a resident-initiated, step-wise, graduated operative curriculum designed to enhance resident autonomy for laparoscopic cholecystectomy for general surgery residents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Education
- What is being tested?
- briefing objectives, intraoperative teaching, and debriefing feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Oct 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Mayo Clinic general surgery residents and attendings across all campuses
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: A Resident-initiated, Step-wise, Competency-based, Graduated Operative Curriculum to Enhance Resident Autonomy for Laparoscopic Cholecystectomy
The goal of this study is to implement and evaluate the need, feasibility and effectiveness of a resident-initiated, step-wise, graduated operative curriculum designed to enhance resident autonomy for laparoscopic cholecystectomy for general surgery residents.
Read the detailed description
The goal of this study is to improve resident autonomy and confidence through detailed and stepwise feedback and to also assess resident and attending perceptions regarding resident skill and autonomy.
- Conditions
- Surgical Education
- Being tested
- briefing objectives, intraoperative teaching, and debriefing feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
briefing objectives, intraoperative teaching, and debriefing feedbackOther
A standardized step-wise operative curriculum amongst general surgeons will be implemented among all general surgery residents. Residents will follow and graduate through this curriculum by initiating a perioperative model of briefing objectives, intraoperative teaching, and debriefing feedback (BID).
| Study group | Role | What they receive |
|---|---|---|
| standardized step-wise operative curriculum | Other | General surgery residents at Mayo Clinic will complete surveys measuring resident autonomy, performance, confidence and case complexity at baseline and postoperatively following laparoscopic cholecystectomy to serve as a pre-intervention baseline.
A standardized step-wise operative curriculum will then be implemented Residents will follow and graduate through this curriculum by initiating a perioperative model of briefing objectives, intraoperative teaching, and debriefing feedback (BID). The effectiveness of the intervention will then be measured by comparing survey results pre and post intervention. Receives: Other: briefing objectives, intraoperative teaching, and debriefing feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Surgical Resident's Autonomy
Measured using a validated Zwisch based survey to compare the rate of progression of surgical resident autonomy performing laparoscopic cholecystectomy pre and post implementation of standardized step-wise operative curriculum
Measured: Baseline, postoperatively approximately one day
Change is Surgical Resident's Operative Skills
Measured using a validated Zwisch based survey to compare the rate of progression of surgical resident operative skills performing laparoscopic cholecystectomy pre and post implementation of standardized step-wise operative curriculum
Measured: Baseline, postoperatively approximately one day
Change in Surgical Resident's Confidence
Measured using a validated Zwisch based survey to compare the rate of progression of surgical resident reported confidence performing laparoscopic cholecystectomy pre and post implementation of standardized step-wise operative curriculum
Measured: Baseline, postoperatively approximately one day
Secondary outcomes (1)
Difference in Surgical Resident and Attending Physician Perceptions
Difference between surgical resident and attending physician's perceptions of progression of resident operative skills performing laparoscopic cholecystectomy pre and post implementation of standardized step-wise operative curriculum using a validated Zwisch based survey.
Measured: Baseline, postoperatively approximately one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start7 Oct 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical EducationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah A. McLaughlin, Mayo Clinic
- Investigators
- Sarah McLaughlin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691206
- Sponsor's protocol ID
- 20-002606
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Resident-initiated, Step-wise, Competency-based, Graduated Operative Curriculum to Enhance Resident Autonomy for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04691206
- Acronym / sponsor ID
- 20-002606
- Conditions
- Surgical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 Dec 2020 (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.
The goal of this study is to implement and evaluate the need, feasibility and effectiveness of a resident-initiated, step-wise, graduated operative curriculum designed to enhance resident autonomy for laparoscopic cholecystectomy for general surgery residents.
Detailed description
The goal of this study is to improve resident autonomy and confidence through detailed and stepwise feedback and to also assess resident and attending perceptions regarding resident skill and autonomy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standardized step-wise operative curriculum | Other | Other: briefing objectives, intraoperative teaching, and debriefing feedbackGeneral surgery residents at Mayo Clinic will complete surveys measuring resident autonomy, performance, confidence and case complexity at baseline and postoperatively following laparoscopic cholecystectomy to serve as a pre-intervention baseline. A standardized step-wise operative curriculum will then be implemented Residents will follow and graduate through this curriculum by initiating a perioperative model of briefing objectives, intraoperative teaching, and debriefing feedback (BID). The effectiveness of the intervention will then be measured by comparing survey results pre and post intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Mayo Clinic general surgery residents and attendings across all campuses
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| briefing objectives, intraoperative teaching, and debriefing feedbackA standardized step-wise operative curriculum amongst general surgeons will be implemented among all general surgery residents. Residents will follow and graduate through this curriculum by initiating a perioperative model of briefing objectives, intraoperative teaching, and debriefing feedback (BID). | Other | standardized step-wise operative curriculum |
Primary outcome
Change in Surgical Resident's Autonomy
Time frame: Baseline, postoperatively approximately one day
Measured using a validated Zwisch based survey to compare the rate of progression of surgical resident autonomy performing laparoscopic cholecystectomy pre and post implementation of standardized step-wise operative curriculum
Change is Surgical Resident's Operative Skills
Time frame: Baseline, postoperatively approximately one day
Measured using a validated Zwisch based survey to compare the rate of progression of surgical resident operative skills performing laparoscopic cholecystectomy pre and post implementation of standardized step-wise operative curriculum
Change in Surgical Resident's Confidence
Time frame: Baseline, postoperatively approximately one day
Measured using a validated Zwisch based survey to compare the rate of progression of surgical resident reported confidence performing laparoscopic cholecystectomy pre and post implementation of standardized step-wise operative curriculum
1 secondary outcome
Difference in Surgical Resident and Attending Physician Perceptions
Time frame: Baseline, postoperatively approximately one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sarah McLaughlin, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing briefing objectives, intraoperative teaching, and debriefing feedback in people with Surgical Education, run by Mayo Clinic at 3 sites in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Surgical Resident's Autonomy (time frame: Baseline, postoperatively approximately one day). The study lists 3 primary outcomes in all. 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 24 Nov 2023.