Operative Curriculum Gallbladder Surgery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Surgical Education
• Intervention / Treatment: Other: briefing objectives, intraoperative teaching, and debriefing feedback

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 Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Baseline, postoperatively approximately one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, postoperatively approximately one day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Sarah McLaughlin, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: October 17, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20-002606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No