Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? (3DRCT)
Primary Purpose
Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Storz 3D Laparoscopy System
2D Laparoscopy
Sponsored by
About this trial
This is an interventional other trial for Uterine Fibroids focused on measuring Laparoscopy, 3D Visual System, Total Hysterectomy
Eligibility Criteria
Inclusion Criteria:
- Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
Exclusion Criteria:
- None
Sites / Locations
- Brigham & Women's Hospital
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2D Laparoscopy
3D laparoscopy
Arm Description
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Outcomes
Primary Outcome Measures
Vaginal Cuff Closure Times
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
Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
Full Information
NCT ID
NCT02192606
First Posted
November 5, 2013
Last Updated
January 18, 2018
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02192606
Brief Title
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
Acronym
3DRCT
Official Title
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain, Adenomyosis
Keywords
Laparoscopy, 3D Visual System, Total Hysterectomy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2D Laparoscopy
Arm Type
Active Comparator
Arm Description
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
Arm Title
3D laparoscopy
Arm Type
Active Comparator
Arm Description
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Intervention Type
Device
Intervention Name(s)
Storz 3D Laparoscopy System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
2D Laparoscopy
Intervention Description
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
Primary Outcome Measure Information:
Title
Vaginal Cuff Closure Times
Description
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.
Time Frame
Start of vaginal cuff closure to end of vaginal cuff closure
Secondary Outcome Measure Information:
Title
Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
Description
The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
Time Frame
Time of Procedure End
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Einarsson, MD, PhD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah L Cohen, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16985832
Citation
Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4.
Results Reference
background
PubMed Identifier
23072406
Citation
Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.
Results Reference
background
Citation
Einarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.
Results Reference
background
PubMed Identifier
31172324
Citation
Ajao MO, Larsen CR, Manoucheri E, Goggins ER, Rask MT, Cox MKB, Mushinski A, Gu X, Cohen SL, Rudnicki M, Einarsson JI. Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial. Surg Endosc. 2020 Mar;34(3):1237-1243. doi: 10.1007/s00464-019-06886-9. Epub 2019 Jun 6.
Results Reference
derived
Learn more about this trial
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
We'll reach out to this number within 24 hrs