Laparoscopic Vaginal Cuff Suturing Profienciency for OBGYN Residents

NCT03360357 | Withdrawn

• 1 other identifier: 17-008825
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A recent survey of obstetrics and gynecology fellowship program directors showed that graduating OB/GYN residents may be underprepared for advanced laparoscopic training, necessitating an evaluation of the current structure of resident and fellow curriculum. Specifically, only 46% of first year fellows were able to independently perform an abdominal hysterectomy. Out of 28 residents tested using a previously validated laparoscopic cuff suturing model, only 8 (28.6%) passed the assessment. For this reason, it is necessary to identify the most effective and efficient educational approaches to obtain procedural proficiency. Time and effort has been placed in developing simulation programs. Simulation has shown promising outcomes in improving the performance of trainees and attending physicians with the ultimate objective of generating better surgeons. A previous meta-analysis of simulation-based educational assessments demonstrated that these assessments correlate positively with patient-related outcomes. However, there are limited studies with adequate validity to use simulation for summative evaluations of performance for gynecology residents. The widely used Fundamentals of Laparoscopic Surgery (FLS) program is used for credentialing of general surgeons, however, a systematic review suggested that more validity evidence is required to support its content (selection of tasks and scoring rubric) and the consequences (favorable and unfavorable impact) assessment. Although there has been an increase in the number of models available to teach OB/GYN common gynecologic procedures, there is a lack of evidence to support that these methods are actually allowing residents to create better surgical skills. To address the current limitations in OB/GYN training, the investigators have developed short, guided drills that cover the steps required for laparoscopic suturing and allow residents opportunities for deliberate practice. These drills will be tested compared to residents watching a laparoscopic suturing video and practicing using a high fidelity, suturing simulation model. Both of these methods are standard educational approaches for teaching laparoscopic skills, but it is unknown if one of the approaches is more effective than the other.

Conditions

Educational Problems

Outcome Measures

Primary Outcomes (1)

• Proficiency of laparoscopic suturing of OBGYN residents

  Vaginal cuff suturing proficiency will be higher in OB/GYN residents assigned to guided laparoscopic drills compared to residents assigned to an education video and high fidelity vaginal cuff suturing simulation model.

  15 minutes

Study Arms (2)

guided drills

EXPERIMENTAL

These people will be going through all the guided drills before being evaluated.

Procedure: Guided drills

Self-trained

NO INTERVENTION

These people will watch a video and be able to practice by themselves without having any direction regarding how and what to practice.

Interventions

Guided drills PROCEDURE

These residents will perform 5 set of exercises: 1. "Needle Dance" (Learning to manipulate the suture) 2. "Loopy Loop" (Learning to place needle through a loop) 3. "Slalom Course" (Passing the needle and suture through 5 rings right handed and left handed) 4. "Dense Matter" (Passing the needle through dense material without losing control of the needle) 5. "Respect for tissue" (Passing the needle through flimsy material without tearing)

guided drills

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current OBGYN residents, fellows, and faculty at ACGME accredited residencies in the United States

You may not qualify if:

• \- Non-current OBGYN residents at at ACGME accredited residencies in the United States

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 4, 2017
• Study Start: September 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share