Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
- Conditions
- Abnormal Uterine BleedingPelvic PainAdenomyosisUterine Fibroids
- Interventions
- Device: Storz 3D Laparoscopy SystemDevice: 2D Laparoscopy
- Registration Number
- NCT02192606
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 57
- Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3D laparoscopy Storz 3D Laparoscopy System The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. 2D Laparoscopy 2D Laparoscopy The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
- Primary Outcome Measures
Name Time Method Vaginal Cuff Closure Times Start of vaginal cuff closure to end of vaginal cuff closure 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.
- Secondary Outcome Measures
Name Time Method Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy Time of Procedure End The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
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Trial Locations
- Locations (2)
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Odense University Hospital
🇩🇰Odense, Denmark