NCT04209036

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: —

Summary

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.

Detailed description

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)

Conditions

• Uterine Fibroid
• Uterine Bleeding
• Uterine Prolapse

Interventions

Type	Name	Description
OTHER	0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)	total laparoscopic hysterectomy using a 3D laparoscopy high-definition system

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-11-01
• Completion: 2020-12-01
• First posted: 2019-12-23
• Last updated: 2019-12-23

Locations

1 site across 1 country: Italy