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Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

Not Applicable
Completed
Conditions
Abnormal Uterine Bleeding
Pelvic Pain
Adenomyosis
Uterine Fibroids
Interventions
Device: Storz 3D Laparoscopy System
Device: 2D Laparoscopy
Registration Number
NCT02192606
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
57
Inclusion Criteria
  • Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
Exclusion Criteria
  • None

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
3D laparoscopyStorz 3D Laparoscopy SystemThe Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
2D Laparoscopy2D LaparoscopyThe standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
Primary Outcome Measures
NameTimeMethod
Vaginal Cuff Closure TimesStart 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
NameTimeMethod
Estimated Blood Loss at the Time of Total Laparoscopic HysterectomyTime of Procedure End

The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.

Trial Locations

Locations (2)

Brigham & Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Odense University Hospital

🇩🇰

Odense, Denmark

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