Uterine FibroidNCT04209036
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
An observational study of Uterine Fibroid and Uterine Bleeding, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Fibroid, Uterine Bleeding, Uterine Prolapse
- What is being tested?
- 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and / or magnetic resonance and / or abdominal CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.
Who may be able to join
- Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy
- 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
Who cannot join
- Suspected neoplastic pathology
- Patients not eligible for surgery
Trial locations and contacts
1 site in 1 country.
Stefano Restaino, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Rome, RM, 00168
Francesco Fanfani, Professor, 0630154979, francesco.fanfani74@gmail.com
Stefano Restaino, MD, restaino.stefano@gmail.com
About this study
Official title: 2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial
Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.
Read the detailed description
All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and/or magnetic resonance and/or CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.
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
- Uterine Fibroid, Uterine Bleeding, Uterine Prolapse
- Being tested
- 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)
- Keywords
- 3D laparoscopy, 2D laparoscopy, surgeons in training
- Medical subject headings
- Leiomyoma, Uterine Hemorrhage, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)Other
total laparoscopic hysterectomy using a 3D laparoscopy high-definition system
| Study group | Role | What they receive |
|---|---|---|
| 3D laparoscopy arm | patients submitted to total hysterectomy using a 3D laparoscopic camera Receives: Other: 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany) | |
| 2D laparoscopy arm | patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy
Measured: intra-operative
Secondary outcomes (2)
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)
Measured: intra-operative
Early post-operative complications
Evaluate the incidence of postoperative complications (need for postoperative transfusions, dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)
Measured: from surgery up to 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Nov 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
- Investigators
- Francesco Fanfani, Professor, Principal investigator, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209036
- Sponsor's protocol ID
- CICOG-30-10-19\48
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34555876
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04209036
- Acronym / sponsor ID
- CICOG-30-10-19\48
- Conditions
- Uterine Fibroid, Uterine Bleeding, Uterine Prolapse
- Keywords
- 3D laparoscopy, 2D laparoscopy, surgeons in training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.
Detailed description
All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and/or magnetic resonance and/or CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D laparoscopy arm | – | Other: 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)patients submitted to total hysterectomy using a 3D laparoscopic camera |
| 2D laparoscopy arm | – | –patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera) |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and / or magnetic resonance and / or abdominal CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.
Key inclusion criteria (6 listed)
- Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy
- Uterine size </= than 15 cm
- American Society of Anesthesiologists (ASA) class < 3
- Patient's informed consent
- No actual pregnancies or pelvic inflammatory disease
Key exclusion criteria (2 listed)
- Suspected neoplastic pathology
- Patients not eligible for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)total laparoscopic hysterectomy using a 3D laparoscopy high-definition system | Other | 3D laparoscopy arm |
Primary outcome
Operative time
Time frame: intra-operative
To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy
2 secondary outcomes
Intra-operative complications
Time frame: intra-operative
Early post-operative complications
Time frame: from surgery up to 30 days from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 34555876Restaino 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Restaino, MD contact
Francesco Fanfani, Professor principal investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid and Uterine Bleeding, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Fanfani, Professor (06 30154979, francesco.fanfani74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04209036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.