Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

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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