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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D laparoscopy arm | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany) | Other | total laparoscopic hysterectomy using a 3D laparoscopy high-definition system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy | intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Early post-operative complications |
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Inclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Fanfani, Professor | Contact | 06 30154979 | francesco.fanfani74@gmail.com | |
| Stefano Restaino, MD | Contact | restaino.stefano@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Fanfani, Professor | Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli, IRCCS | Recruiting | Rome | RM | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34555876 | Derived | 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. |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D014592 | Uterine Hemorrhage |
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Evaluate the incidence of postoperative complications (need for postoperative transfusions, dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections) |
| from surgery up to 30 days from surgery |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |