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Brief Title: Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
Official Title: Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy
Study ID: NCT02192606
Brief Summary: The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.
Detailed Description: This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Brigham & Women's Hospital, Boston, Massachusetts, United States
Odense University Hospital, Odense, , Denmark
Name: Jon Einarsson, MD, PhD, MPH
Affiliation: Brigham and Women's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Sarah L Cohen, MD, MPH
Affiliation: Brigham and Women's Hospital
Role: STUDY_DIRECTOR