Clinical trial NCT01916343: Laparoscopic Gynecology Curriculum for Residents
Official title: Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy for Abnormal Uterine Bleeding
Keywords: Laparoscopy
Surgical skills
Team training
Obstetrics and Gynecology
Curriculum
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Technical Performance Score
timeFrame: 9 months
Secondary outcomes:
measure: Cognitive Test Scores
timeFrame: 5 months
measure: Surgical Skills
timeFrame: 5 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Teodor Grantcharov, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.