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Female Urogenital Diseases and Pregnancy Complications

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.

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.

Storz 3D Laparoscopy System

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

2D Laparoscopy

Jon Einarsson, MD, PhD, MPH

Sarah L Cohen, MD, MPH

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.

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.

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

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.

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

Brigham and Women's Hospital

Division Chair, Minimally Invasive Gynecology

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

2D Laparoscopy: 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.

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.

3D Laparoscopy

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Denmark

Region of Enrollment

Jon I. Einarsson

Vaginal Cuff Closure Times

Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy

Overall Study

Prolapse

Uterine Prolapse

Pathological Conditions, Anatomical

Pelvic Organ Prolapse

patients submitted to total hysterectomy using a 3D laparoscopic camera

patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera)

total laparoscopic hysterectomy using a 3D laparoscopy high-definition system

0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)

Francesco Fanfani, Professor

Stefano Restaino, MD

Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and/or magnetic resonance and/or CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.

While under general anesthesia, the patient is positioned in the dorsal lithotomic position with both legs supported in stirrups with a Trendelenburg tilt and arms along the body. A four disposable or reusable, sterile trocar transperitoneal approach is used. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope (HD EndoEye 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany). The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system. Clermont Ferrand uterine manipulator (Model K.Storz Endoskope,Tuttlingen, Germany) is optionally used to move the uterus.

Total hysterectomy is then performed according to standard technique used by the recruiting center (development of the pararectal space and identification of uterine artery, coagulation of ovarian pedicles, development of the vesico-uterine septum, colpotomy).The vaginal vault is then closed with a 0 Vycril suture laparoscopically (continuous suture).

Detailed operative time, intra and post operative early complications will be recorded (Extended Clavien-Dindo classification of surgical complications will be used for post operative complications)

Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?

2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial

To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy

• Evaluate the incidence of intraoperative complications in the two laparoscopic system (intraoperative blood loss, need for intraoperative transfusions, bladder lesions, ureteral lesions, vascular lesions, intestinal lesions)

Evaluate the incidence of postoperative complications (need for postoperative transfusions, dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?	NCT02192606	Uterine Fibroid... Abnormal Uterin... Pelvic Pain Adenomyosis	Storz 3D Laparo... 2D Laparoscopy	18 Years - 80 Years	Brigham and Women's Hospital
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?	NCT02192606	Uterine Fibroid... Abnormal Uterin... Pelvic Pain Adenomyosis	Storz 3D Laparo... 2D Laparoscopy	18 Years - 80 Years	Brigham and Women's Hospital
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?	NCT04209036	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...	0° 3D laparosco...	-	Catholic University of the Sacred Heart
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?	NCT04209036	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...	0° 3D laparosco...	-	Catholic University of the Sacred Heart

Spots Global Cancer Trial Database for 2d laparoscopy