This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.
PRIMARY OBJECTIVE: I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures. OUTLINE: Patients undergo surgery using the da Vinci SP1098 robotic system on study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
33
Undergo surgery using the da Vinci SP device
City of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGConversion of operation to laparotomy
The number and frequency will be reported with 95% confidence intervals.
Time frame: Within 30 days of operation
Incidence of major surgical complications
Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.
Time frame: Within 30 days of operation
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