NCT04691206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

October 17, 2020

Last Update Submit

November 22, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Difference in Surgical Resident and Attending Physician Perceptions

    Baseline, postoperatively approximately one day

Study Arms (1)

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.

Other: briefing objectives, intraoperative teaching, and debriefing feedback

Interventions

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).

standardized step-wise operative curriculum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Sarah McLaughlin, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2020

First Posted

December 31, 2020

Study Start

October 7, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations