Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis
Conditions
Keywords
Robotic Surgery, Telelap-ALFX, Gynecological disease
Brief summary
Phase II prospective single-institutional study.
Detailed description
The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.
Interventions
DEVICETelelap ALF-X
Patients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit. Through the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure.
Sponsors
SOFAR S.p.A.
Catholic University of the Sacred Heart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* informed consent * 30 ≤ BMI \< 40 * ASA \< III * Ovarian Cyst * Prophylactic bilateral salpingo-oophorectomy * Ectopic Pregnancy * Pelvic Inflammatory Disease * Sterility/Infertility * Benign uterine disease (fibromatosis, adenomyosis) * Endometrial hiperplasia * Early-stage Endometrial Cancer * Preneoplastic lesions of the cervix * IA1 Cervical Cancer * Pelvic endometriosis
Exclusion criteria
* Pregnancy * Liver disease * Coagulopathies * Clinical conditions contraindicating laparoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative complication rate | intraoperative | Operative time, conversion rate, estimated blood loss, visceral injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complication rate | 30 days | Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death |
Countries
Italy
Contacts
Primary ContactSalvatore Gueli Alletti, MD
Backup ContactSalvatore Gueli Alletti, MD
Outcome results
None listed