Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? (3DRCT)

January 18, 2018 updated by: Jon I. Einarsson, Brigham and Women's Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark
        • Odense University Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Start of vaginal cuff closure to end of vaginal cuff closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time of Procedure End

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3DRCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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