Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
NCT ID: NCT04209036
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
22 participants
OBSERVATIONAL
2019-11-01
2020-12-01
Brief Summary
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Detailed Description
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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° high-definition telescope (HD EndoEye 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany). 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 used by the recruiting center (development of the pararectal space and identification of uterine artery, coagulation of ovarian pedicles, development of the vesico-uterine septum, colpotomy).The vaginal vault is then closed with a 0 Vycril suture laparoscopically (continuous suture).
Detailed operative time, intra and post operative early complications will be recorded (Extended Clavien-Dindo classification of surgical complications will be used for post operative complications)
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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3D laparoscopy arm
patients submitted to total hysterectomy using a 3D laparoscopic camera
0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)
total laparoscopic hysterectomy using a 3D laparoscopy high-definition system
2D laparoscopy arm
patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera)
No interventions assigned to this group
Interventions
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0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)
total laparoscopic hysterectomy using a 3D laparoscopy high-definition system
Eligibility Criteria
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Inclusion Criteria
* Uterine size \</= than 15 cm
* American Society of Anesthesiologists (ASA) class \< 3
* Patient's informed consent
* No actual pregnancies or pelvic inflammatory disease
* No previous major abdominal surgical procedures
Exclusion Criteria
* Patients not eligible for surgery
FEMALE
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Prof. Giovanni Scambia
Professor
Principal Investigators
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Francesco Fanfani, Professor
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Locations
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Fondazione Policlinico Universitario A. Gemelli, IRCCS
Rome, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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Francesco Fanfani, Professor
Role: primary
Stefano Restaino, MD
Role: backup
References
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Restaino S, Vargiu V, Rosati A, Bruno M, Dinoi G, Cola E, Moroni R, Scambia G, Fanfani F. 4K versus 3D total laparoscopic hysterectomy by resident in training: a prospective randomised trial. Facts Views Vis Obgyn. 2021 Sep;13(3):221-229. doi: 10.52054/FVVO.13.3.027.
Other Identifiers
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CICOG-30-10-19\48
Identifier Type: -
Identifier Source: org_study_id