NCT03360357

Laparoscopic Vaginal Cuff Suturing Profienciency for OBGYN Residents

Withdrawn NA Last updated 13 April 2020

What this trial tests

NA trial testing Guided drills in Educational Problems. Withdrawn.

Timeline

1 September 2019

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Start date	1 September 2019
Primary completion	30 September 2020
Estimated completion	30 September 2020

Drugs / interventions tested

• Guided drills

Conditions studied

• Educational Problems — all drugs for Educational Problems →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Educational Problems. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.