Clinical trial NCT04637022: 4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial
Official title: 4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Fibroid
Uterine Bleeding
Uterine Prolapse
Keywords: 4k laparoscopy
3d laparoscopy
surgeons in training
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 CT) and with indication for total laparoscopic hysterectomy with consequently need for laparoscopic suture of the vaginal cuff, will be enrolled in the study.

Brief summary: This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

Detailed description: All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and / or magnetic resonance and / or CT) and with indication for total laparoscopic hysterectomy with consequently need for laparoscopic suture of the vaginal cuff, will be enrolled in the study.

- I TIME/OUT OF PROTOCOL TIME (performed by expert surgeons) 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° 4K high-definition telescope (VISERA UHD 4K 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany).

Two additional 5 mm ports are placed under direct visualization, in the right lower abdomen medial to the right obliterated umbilical artery and in the left lower abdomen lateral to the inferior epigastric vessels. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. 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.

- II TIME/PROTOCOL TIME (performed by surgeon in training) The vaginal vault is closed with a 0 Vycril suture laparoscopically (continuous suture). In order to avoid excess operating time, 15 min was allocated for completion of cuff closure by surgeons-in-training, after which time the attending surgeon took over this task.

Operative time, estimated blood loss, incidence of intra or post-operative complications, postoperative pain, days of hospitalization and costs will be recordered

Eligibility criteria: Inclusion Criteria:

* Patients suffering from benign gynecological pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy and consequently need for laparoscopic suture of the vaginal cuff
* American Society of Anesthesiologists (ASA) class \< 3
* Patient's informed consent

Exclusion Criteria:

* Suspected neoplastic pathology
* Patients not eligible for surgery
* Actual pregnancies or pelvic inflammatory disease

Primary outcomes:
measure: operative time
timeFrame: intra-operative
Secondary outcomes:
measure: Intra-operative complications
timeFrame: intra-operative
Other outcomes:
measure: post-operative complications
timeFrame: up to 3 months
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli, IRCCS
state: RM
Study officials:
References: