Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain, Adenomyosis

Intervention / Treatment
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* Device: Storz 3D Laparoscopy System
* Device: 2D Laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D Laparoscopy<br>The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy | Device: 2D Laparoscopy<br>* The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.<br>|
| Active Comparator: 3D laparoscopy<br>The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. | Device: Storz 3D Laparoscopy System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, 3D Visual System, Total Hysterectomy