Laparoscopic Gynecology Curriculum for Residents

NCT01916343 | Completed

• 1 other identifier: 12-159
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hysterectomy for Abnormal Uterine Bleeding

Keywords

Laparoscopy; Surgical skills; Team training; Obstetrics and Gynecology; Curriculum

Outcome Measures

Primary Outcomes (1)

• Technical Performance Score

  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.

  9 months

Secondary Outcomes (2)

• Cognitive Test Scores

  5 months

• Surgical Skills

  5 months

Study Arms (2)

Study Laparoscopic Curriculum

EXPERIMENTAL

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

Standard Clinical Education

NO INTERVENTION

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.

Interventions

Study Laparoscopic Curriculum PROCEDURE

Study Laparoscopic Curriculum

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• Larsen CR, Grantcharov T, Schouenborg L, Ottosen C, Soerensen JL, Ottesen B. Objective assessment of surgical competence in gynaecological laparoscopy: development and validation of a procedure-specific rating scale. BJOG. 2008 Jun;115(7):908-16. doi: 10.1111/j.1471-0528.2008.01732.x.

  PMID: 18485171 BACKGROUND

Study Officials

• Teodor Grantcharov, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: August 5, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

CA (1)