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Operative Curriculum Gallbladder Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04691206
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2020
Last Update Posted : January 3, 2022
Sponsor:
Information provided by (Responsible Party):
Sarah A. McLaughlin, Mayo Clinic

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Surgical Education Other: briefing objectives, intraoperative teaching, and debriefing feedback Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Resident-initiated, Step-wise, Competency-based, Graduated Operative Curriculum to Enhance Resident Autonomy for Laparoscopic Cholecystectomy
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022
Arms and Interventions
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Arm Intervention/treatment
standardized step-wise operative curriculum

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.

 Other: briefing objectives, intraoperative teaching, and debriefing feedback
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Difference in Surgical Resident and Attending Physician Perceptions [ Time Frame: Baseline, postoperatively approximately one day ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All Mayo Clinic general surgery residents and attendings across all campuses

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691206


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sarah McLaughlin, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Sarah A. McLaughlin, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04691206    
Other Study ID Numbers: 20-002606
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No