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Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

NCT02192606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-01-24

Study results available
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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.

Conditions

  • Uterine Fibroids
  • Abnormal Uterine Bleeding
  • Pelvic Pain
  • Adenomyosis

Interventions

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.

DEVICE

2D Laparoscopy

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Jon Einarsson, MD, PhD, MPH · Brigham and Women's Hospital

  • Sarah L Cohen, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • United States
  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02192606 on ClinicalTrials.gov