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Laparoscopic Vaginal Cuff Suturing Profienciency for OBGYN Residents

NCT03360357 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-04-13

No results posted yet for this study

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

Interventions

PROCEDURE

Guided drills

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-09-30
Completion
2020-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360357 on ClinicalTrials.gov