Hysterectomy for Abnormal Uterine Bleeding Clinical Trial
Official title:
Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents
| NCT number | NCT01916343 |
| Other study ID # | 12-159 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2013 |
| Est. completion date | December 2013 |
| Verified date | February 2019 |
| Source | St. Michael's Hospital, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| St. Michael's Hospital, Toronto |
Canada,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | 5 months | |
| Secondary | Surgical Skills | To determine if the proposed laparoscopic curriculum will improve resident scores assessed by cognitive and technical skills examination. | 5 months |