Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX

Study Overview
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Brief Summary
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Phase II prospective single-institutional study.

Detailed Description
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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.

Conditions
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Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Intervention / Treatment
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* Device: Telelap ALF-X


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telelap ALF-X in obese patients with gynecological disease<br> | Device: Telelap ALF-X<br>* 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.<br>* Other names: ALF-X teleassisted surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative complication rate | Operative time, conversion rate, estimated blood loss, visceral injury | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complication rate | Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Surgery, Telelap-ALFX, Gynecological disease