Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? (3DRCT)
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|ClinicalTrials.gov Identifier: NCT02192606|
Recruitment Status : Completed
First Posted : July 17, 2014
Results First Posted : October 6, 2017
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids Abnormal Uterine Bleeding Pelvic Pain Adenomyosis||Device: Storz 3D Laparoscopy System Device: 2D Laparoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
Active Comparator: 2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
Device: 2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
Active Comparator: 3D laparoscopy
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Device: 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.
- Vaginal Cuff Closure Times [ Time Frame: 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.
- Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy [ Time Frame: Time of Procedure End ]The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192606
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Odense University Hospital|
|Principal Investigator:||Jon Einarsson, MD, PhD, MPH||Brigham and Women's Hospital|
|Study Director:||Sarah L Cohen, MD, MPH||Brigham and Women's Hospital|