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

Uterine Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637022
• Other study ID #: DIPUSVSP-27-07-2088
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: January 2021
• Source: Catholic University of the Sacred Heart
• Contact: Francesco Fanfani, Professor
• Phone: 06 30154979
• Email: francesco.fanfani74[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Prolapse
• Uterine Bleeding
• Uterine Fibroid
• Uterine Hemorrhage
• Uterine Prolapse

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli, IRCCS	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post-operative complications	- Evaluate the incidence of postoperative complications (dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)	up to 3 months
Primary	operative time	To compare the time taken to close the vaginal cuff, which was defined as time, starting from the initial grasp of the suture to cutting the suture, with 3D Laparoscopy vs 4K laparoscopy	intra-operative
Secondary	Intra-operative complications	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)	intra-operative