NCT02338505

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-01-14
• Last updated: 2015-01-14

Locations

1 site across 1 country: Italy