CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
Storz 3D Laparoscopy System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02192606
NCT02192606N/ACompleted

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

Brigham and Women's Hospital·interventional·Posted Jul 17, 2014·Updated Jan 24, 2018

In Brief

A clinical study evaluating Storz 3D Laparoscopy System and 2D Laparoscopy for Uterine Fibroids and 3 related conditions. Completed, enrolled 57 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, United States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 17, 2014
Enrollment StartNov 1, 2013
Primary CompletionAug 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.0 years ago

Interventions

Storz 3D Laparoscopy Systemdevice

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.

2D Laparoscopydevice

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