NCT02192606

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DEVICE	2D Laparoscopy	The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2014-07-17
• Last updated: 2018-01-24
• Results posted: 2017-10-06

Locations

2 sites across 2 countries: United States, Denmark