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| Name | Class |
|---|---|
| SOFAR S.p.A. | INDUSTRY |
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Phase II prospective single-institutional study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telelap ALF-X in obese patients with gynecological disease | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telelap ALF-X | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative complication rate | Operative time, conversion rate, estimated blood loss, visceral injury | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complication rate | Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salvatore Gueli Alletti, MD | Contact | gueliallettis@gmail.com | ||
| Salvatore Gueli Alletti, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart Rome, | Rome | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23225591 | Result | Gidaro S, Buscarini M, Ruiz E, Stark M, Labruzzo A. Telelap Alf-X: a novel telesurgical system for the 21st century. Surg Technol Int. 2012 Dec;22:20-5. | |
| 24706079 | Result | Gidaro S, Altobelli E, Falavolti C, Bove AM, Ruiz EM, Stark M, Ravasio G, Lazzaretti SS, Maurizio B. Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study. Surg Technol Int. 2014 Mar;24:35-40. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 25225214 | Result | Lococo A, Larocca V, Marino F, De Filippis AF, Cesario A, Lococo F. Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model. Surg Innov. 2015 Jun;22(3):252-6. doi: 10.1177/1553350614549633. Epub 2014 Sep 15. |
| 25433265 | Result | Falavolti C, Gidaro S, Ruiz E, Altobelli E, Stark M, Ravasio G, Ravasio G, Lazzaretti SS, Buscarini M. Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study. Surg Technol Int. 2014 Nov;25:37-41. |
| D000091662 | Genital Diseases |