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

• Conditions: Uterine Bleeding; Uterine Prolapse; Uterine Fibroid
• Interventions: Other: 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)

• Registration Number: NCT04209036
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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)

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-20
• Last Update Submitted: 2019-12-20
• Study First Posted: 2019-12-23
• Last Update Posted: 2019-12-23
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy
• Uterine size </= than 15 cm
• American Society of Anesthesiologists (ASA) class < 3
• Patient's informed consent
• No actual pregnancies or pelvic inflammatory disease
• No previous major abdominal surgical procedures

Exclusion Criteria

• Suspected neoplastic pathology
• Patients not eligible for surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3D laparoscopy arm	0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)	patients submitted to total hysterectomy using a 3D laparoscopic camera

Primary Outcome Measures

Name	Time	Method
Operative time	intra-operative	To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy

Secondary Outcome Measures

Name	Time	Method
Intra-operative complications	intra-operative	• 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)
Early post-operative complications	from surgery up to 30 days from surgery	Evaluate the incidence of postoperative complications (need for postoperative transfusions, dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS; 🇮🇹 Rome, RM, Italy