4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Uterine Bleeding; Uterine Prolapse; Uterine Fibroid

Study type: Observational

Funder types: Other

Identifiers

NCT04637022

DIPUSVSP-27-07-2088

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

3D laparoscopy arm

Description:

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 3D laparoscopic camera

4k laparoscopy arm

Description:

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 4k laparoscopic camera