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
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.
Study Type
Interventional
Primary Outcome
Vaginal Cuff Closure Times
Secondary Outcome
Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
Condition
Uterine Fibroids
Intervention
Storz 3D Laparoscopy System
Study Arms / Comparison Groups
2D Laparoscopy
Description: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
57
Start Date
November 2013
Completion Date
September 2016
Primary Completion Date
August 2016
Eligibility Criteria
Inclusion Criteria: - Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding Exclusion Criteria: - None
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jon Einarsson, MD, PhD, MPH, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT02192606
Organization ID
3DRCT
Responsible Party
Principal Investigator
Study Sponsor
Brigham and Women's Hospital
Study Sponsor
Jon Einarsson, MD, PhD, MPH, Principal Investigator, Brigham and Women's Hospital
Verification Date
January 2018