4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial
NCT ID: NCT04637022
Last Updated: 2021-01-26
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2021-01-25
2021-09-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
NCT04209036
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy
NCT04358978
3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy
NCT04070872
Evaluation of the Uterine Cavity After Operative Hysteroscopy
NCT06924437
Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
NCT02367703
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
\- 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
3D laparoscopy arm
Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 3D laparoscopic camera
No interventions assigned to this group
4k laparoscopy arm
Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 4k laparoscopic camera
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* American Society of Anesthesiologists (ASA) class \< 3
* Patient's informed consent
Exclusion Criteria
* Patients not eligible for surgery
* Actual pregnancies or pelvic inflammatory disease
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Catholic University of the Sacred Heart
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Giovanni Scambia
professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Rome, RM, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DIPUSVSP-27-07-2088
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.