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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Unknown status

CT.gov ID

NCT04209036

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroid Uterine Bleeding Uterine Prolapse	Other: 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)

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 Design

Study Type:

Observational

Anticipated Enrollment :

22 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
3D laparoscopy arm patients submitted to total hysterectomy using a 3D laparoscopic camera	Other: 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany) total laparoscopic hysterectomy using a 3D laparoscopy high-definition system
2D laparoscopy arm patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera)

Arm

Intervention/Treatment

3D laparoscopy arm

patients submitted to total hysterectomy using a 3D laparoscopic camera

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

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

2D laparoscopy arm

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

Outcome Measures

Primary Outcome Measures

Operative time [intra-operative]
To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

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