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Laparoscopic Gynecology Curriculum for Residents

Primary Purpose

Hysterectomy for Abnormal Uterine Bleeding

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Study Laparoscopic Curriculum
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hysterectomy for Abnormal Uterine Bleeding focused on measuring Laparoscopy, Surgical skills, Team training, Obstetrics and Gynecology, Curriculum

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Laparoscopic Curriculum

Standard Clinical Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2013
Last Updated
February 20, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01916343
Brief Title
Laparoscopic Gynecology Curriculum for Residents
Official Title
Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy for Abnormal Uterine Bleeding
Keywords
Laparoscopy, Surgical skills, Team training, Obstetrics and Gynecology, Curriculum

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Laparoscopic Curriculum
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Clinical Education
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Study Laparoscopic Curriculum
Primary Outcome Measure Information:
Title
Technical Performance Score
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Cognitive Test Scores
Description
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.
Time Frame
5 months
Title
Surgical Skills
Description
To determine if the proposed laparoscopic curriculum will improve resident scores assessed by cognitive and technical skills examination.
Time Frame
5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teodor Grantcharov, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18485171
Citation
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.
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Laparoscopic Gynecology Curriculum for Residents

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