Clinical trial NCT04209036: Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
Official title: 2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Fibroid
Uterine Bleeding
Uterine Prolapse
Keywords: 3D laparoscopy
2D laparoscopy
surgeons in training
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and / or magnetic resonance and / or abdominal CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: intra-operative
Secondary outcomes:
measure: Intra-operative complications
timeFrame: intra-operative
measure: Early post-operative complications
timeFrame: from surgery up to 30 days from surgery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli, IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
name: Francesco Fanfani, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Restaino S, Vargiu V, Rosati A, Bruno M, Dinoi G, Cola E, Moroni R, Scambia G, Fanfani F. 4K versus 3D total laparoscopic hysterectomy by resident in training: a prospective randomised trial. Facts Views Vis Obgyn. 2021 Sep;13(3):221-229. doi: 10.52054/FVVO.13.3.027.