Completed

NCT Number: NCT01916343

Laparoscopic Gynecology Curriculum for Residents

Gynecologists are currently using laparoscopy to perform many surgeries traditionally approached by laparotomy. The technical skills required for laparoscopic surgery are different than the skills required for laparotomy, causing a prolonged learning curve. Currently there is no standardized laparoscopy curriculum for gynecology residents. This study aims to develop a specific evidence-based surgical skills gynecologic curriculum that could be instituted in residency programs at a national and international level. The investigators will then validate the curriculum using Obstetrics and Gynecology residents through a cognitive examination, a technical skills examination, and a video recording of performance in the operating room.

HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team training exercises. The investigators hypothesize that residents in the experimental curriculum-trained group will perform better than the residents in the traditional residency curriculum-trained group on a cognitive examination, a technical skills examination, and in the operating room. The operating room performance will be judged by blinded experts on a previously validated evaluation tool.

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Key information

Conditions

Hysterectomy for Abnormal Uterine Bleeding

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Novice residents (defined as having performed less than 10 laparoscopic salpingectomies)
Patients undergoing uncomplicated right-sided salpingectomies prophylactically at the time of laparoscopic hysterectomy, laparoscopic salpingo-ophorectomies, or laparoscopic-assisted vaginal hysterectomies.

Exclusion criteria

Residents who have performed more than 10 laparoscopic salpingectomies
Residents in PGY3 or higher
Patients with multiple prior abdominal surgeries, high BMI, significant adnexal pathology, and extensive endometriosis

Treatment and study plan

Study Laparoscopic Curriculum

Procedure

Primary outcomes

Technical Performance Score

Time frame: 9 months

Technical performance score will be assessed via a previously validated tool known as the OSA-LS (Objective Structured Assessment of Laparoscopic Salpingectomy), with the score received on the OSA-LS being equivalent to their technical score. The OSA-LS is based on the OSATS9, along with a rating scale that has been modified for laparoscopic cholecystectomy. The latter was developed by the primary investigator, Dr. Teodor Grantcharov, and consists of both a reduced global rating scale (GRS) made suitable for laparoscopic surgery, along with a task-specific rating scale known as the operative component rating scale (OCRS). Previously in a pilot study, ten video recorded operations were assessed in order to standardize assessments and to make adjustments to the overall scale. Residents will be video recorded performing a salpingectomy in the operating room. These recordings will be then be scored as per the OSA-LS, by a blinded observer in order to generate an overall assessment.

Secondary outcomes

Cognitive Test Scores

Time frame: 5 months

The cognitive training component of the curriculum will consist of of self-directed reading and video-based learning. Participants will learn theoretical principals and management of post operative complications due to laparoscopic gynecologic surgery and watch videos of gynecologic procedures with an expert facilitator.
Surgical Skills

Time frame: 5 months

To determine if the proposed laparoscopic curriculum will improve resident scores assessed by cognitive and technical skills examination.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 5, 2013
Registry last updated: Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.