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

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Recruiting
CT.gov ID
NCT04637022
Collaborator
(none)
50
1
7.5
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial
    Actual Study Start Date :
    Jan 25, 2021
    Anticipated Primary Completion Date :
    Sep 10, 2021
    Anticipated Study Completion Date :
    Sep 10, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    3D laparoscopy arm

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

    4k laparoscopy arm

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

    Outcome Measures

    Primary Outcome Measures

    1. operative time [intra-operative]

      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

    Secondary Outcome Measures

    1. Intra-operative complications [intra-operative]

      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)

    Other Outcome Measures

    1. post-operative complications [up to 3 months]

      - Evaluate the incidence of postoperative complications (dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario A. Gemelli, IRCCS Rome RM Italy 00168

    Sponsors and Collaborators

    • Catholic University of the Sacred Heart

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Giovanni Scambia, professor, Catholic University of the Sacred Heart
    ClinicalTrials.gov Identifier:
    NCT04637022
    Other Study ID Numbers:
    • DIPUSVSP-27-07-2088
    First Posted:
    Nov 19, 2020
    Last Update Posted:
    Jan 26, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof. Giovanni Scambia, professor, Catholic University of the Sacred Heart
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2021