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Pelvic Organ Prolapse

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 3D laparoscopic camera

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 4k laparoscopic camera

Francesco Fanfani, Professor

Stefano Restaino, MD

This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

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

- I TIME/OUT OF PROTOCOL TIME (performed by expert surgeons) 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° 4K high-definition telescope (VISERA UHD 4K 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany).

Two additional 5 mm ports are placed under direct visualization, in the right lower abdomen medial to the right obliterated umbilical artery and in the left lower abdomen lateral to the inferior epigastric vessels. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. 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.

- II TIME/PROTOCOL TIME (performed by surgeon in training) The vaginal vault is closed with a 0 Vycril suture laparoscopically (continuous suture). In order to avoid excess operating time, 15 min was allocated for completion of cuff closure by surgeons-in-training, after which time the attending surgeon took over this task.

Operative time, estimated blood loss, incidence of intra or post-operative complications, postoperative pain, days of hospitalization and costs will be recordered

4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial

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

To compare the time taken to close the vaginal cuff, which was defined as time, starting from the initial grasp of the suture to cutting the suture, with 3D Laparoscopy vs 4K 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)

Catholic University of the Sacred Heart

professor

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)

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
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	Catholic University of the Sacred Heart
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	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
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	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 surgeons in training