Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

Pelvic Pain Clinical Trial

— 3DRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192606
• Other study ID #: 3DRCT
• Status: Completed
• Phase: N/A
• First received: November 5, 2013
• Last updated: January 18, 2018
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: January 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Countries where clinical trial is conducted

United States,  Denmark, 

References & Publications (3)

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. — View 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Start of vaginal cuff closure to end of vaginal cuff closure
Secondary	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.	Time of Procedure End