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