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

Uterine Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209036
• Other study ID #: CICOG-30-10-19\48
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2019
• Source: Catholic University of the Sacred Heart
• Contact: Francesco Fanfani, Professor
• Phone: 06 30154979
• Email: francesco.fanfani74[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Prolapse
• Uterine Bleeding
• Uterine Fibroid
• Uterine Hemorrhage
• Uterine Prolapse

Intervention

Other:
• 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)
total laparoscopic hysterectomy using a 3D laparoscopy high-definition system

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli, IRCCS	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy	intra-operative
Secondary	Intra-operative complications	• 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)	intra-operative
Secondary	Early post-operative complications	Evaluate the incidence of postoperative complications (need for postoperative transfusions, dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)	from surgery up to 30 days from surgery