Laparoscopic Gynecology Curriculum for Residents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01916343
First received: June 19, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Hysterectomy for Abnormal Uterine Bleeding
Procedure: Study Laparoscopic Curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Technical Performance Score [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Cognitive Test Scores [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine if the proposed laparoscopic curriculum will improve resident scores assessed by cognitive and technical skills examination.


Enrollment: 27
Study Start Date: July 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Laparoscopic Curriculum
Residents will perform a salpingectomy in the operating room, which will be video-recorded through the laparoscopic camera. The residents in the intervention group will then complete the salpingectomy at the conclusion of the curriculum. Following the completion of the curriculum, residents in the intervention group will undergo a multiple-choice examination as well as a repeat skills examination.
Procedure: Study Laparoscopic Curriculum
No Intervention: Standard Clinical Education
Residents will perform a salpingectomy in the operating room, which will be video-recorded through the laparoscopic camera. The standard clinical education residents will perform the procedure as per standard of care.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916343

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Teodor Grantcharov, MD St. Michael's Hospital, Toronto
  More Information

Publications:
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01916343     History of Changes
Other Study ID Numbers: REB#12-159
Study First Received: June 19, 2013
Last Updated: May 23, 2014
Health Authority: Canada: Institutional Review Board

Keywords provided by St. Michael's Hospital, Toronto:
Laparoscopy
Surgical skills
Team training
Obstetrics and Gynecology
Curriculum

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 20, 2014