Operative Curriculum Gallbladder Surgery

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04691206
• Collaborator: (none)
• Enrollment: 155
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 23.8
• Patients Per Site: 51.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Oct 7, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Change in Surgical Resident's Autonomy [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Sarah McLaughlin, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Sarah A. McLaughlin, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04691206
• Other Study ID Numbers: 20-002606
• First Posted: Dec 31, 2020
• Last Update Posted: Jan 3, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 3, 2022