A Phase 2 interventional study of Telelap ALF-X in Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-01-14.
Sponsored by Catholic University of the Sacred Heart · Phase 2, Interventional, and Treatment
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.
254 studies on the registry are indexed under Precancerous Conditions; 28 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 163 interventional studies indexed under Precancerous Conditions.
Browse Precancerous Conditions studies →Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Device: Telelap 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.
Also known as: ALF-X teleassisted surgery
intraoperative complication rate
Operative time, conversion rate, estimated blood loss, visceral injury
Time frame: intraoperative
postoperative complication rate
Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death
Time frame: 30 days
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Catholic University of the Sacred Heart