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Female Urogenital Diseases and Pregnancy Complications

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy

The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.

The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.

Storz 3D Laparoscopy System

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.

2D Laparoscopy

Jon Einarsson, MD, PhD, MPH

Sarah L Cohen, MD, MPH

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.

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.

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy

The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.

The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.

Brigham and Women's Hospital

Division Chair, Minimally Invasive Gynecology

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy

2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.

The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.

Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?	NCT02192606	Uterine Fibroid... Abnormal Uterin... Pelvic Pain Adenomyosis	Storz 3D Laparo... 2D Laparoscopy	18 Years - 80 Years	Brigham and Women's Hospital
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?	NCT02192606	Uterine Fibroid... Abnormal Uterin... Pelvic Pain Adenomyosis	Storz 3D Laparo... 2D Laparoscopy	18 Years - 80 Years	Brigham and Women's Hospital

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