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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
Sponsor:
Information provided by (Responsible Party):
Jon I. Einarsson, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Abnormal Uterine Bleeding Pelvic Pain Adenomyosis Device: Storz 3D Laparoscopy System Device: 2D Laparoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Denmark
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Jon Einarsson, MD, PhD, MPH Brigham and Women's Hospital
Study Director: Sarah L Cohen, MD, MPH Brigham and Women's Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jon I. Einarsson, Division Chair, Minimally Invasive Gynecology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02192606     History of Changes
Other Study ID Numbers: 3DRCT
First Posted: July 17, 2014    Key Record Dates
Results First Posted: October 6, 2017
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jon I. Einarsson, Brigham and Women's Hospital:
Laparoscopy
3D Visual System
Total Hysterectomy

Additional relevant MeSH terms:
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Pelvic Pain
Leiomyoma
Myofibroma
Uterine Hemorrhage
Adenomyosis
Pain
Neurologic Manifestations
Signs and Symptoms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes