By John Gever, Senior Editor, MedPage Today
June 21, 2011
MedPage Today Action Points
•Explain that outcomes were just as good with robotic single-port cholecystectomy as with conventional laparoscopic procedures in a pilot study of 10 patients.
•Note that mean operating room time was nearly identical with the robotic procedure and conventional multiport laparoscopy.
Outcomes were just as good with robotic single-port cholecystectomy as with conventional laparoscopic procedures in a pilot study, researchers said.
The robotic surgery was attempted in 10 patients and completed in nine, with the same average operating room time as in 10 standard laparascopic gallbladder removals, according to Sherry Wren, MD, and Myriam Curet, MD, of Stanford University and the Palo Alto VA Health Care System.
No serious adverse events were seen after the robotic procedures, the first such single-port surgeries conducted with Intuitive Surgical's da Vinci Si system, the researchers wrote online in Archives of Surgery.
Both physicians were affiliated with Intuitive Surgical -- Wren as a consultant and Curet as chief medical advisor.
In their Archives report, they explained that single-port laparascopic surgery has attracted interest in recent years because of the possibility of reduced pain, faster recovery, and less scarring.
They cited a recent review that counted more than 4,500 patients having received single-port procedures for a variety of purposes.
But, Wren and Curet noted, "there has not been a large clinical trial comparing [single-port] surgery versus standard multiport laparoscopy, so the clinical benefits of this new technique are purely speculative.
They did not have the resources to conduct such a study themselves, but they were able to compare outcomes in the first 10 cholecystecomies they attempted with the da Vinci Si system with the last 10 multiport laparoscopic procedures Wren had performed at the Palo Alto VA hospital.
Seven of the patients undergoing single-port surgery were male and were otherwise representative of the usual VA population, Wren and Curet indicated.
The one single-port procedure that could not be completed involved a patient with significant adhesions of the omentum to the diaphragm, such that it was necessary to use, first, multiport laparoscopy and then open surgery to finally remove the diseased organ, the researchers explained. That patient was not included in the analysis of procedure time.
Among the nine patients with completed single-port surgeries, the mean operating room time was 105 minutes (SD 18), compared with 106 minutes (SD 24) for the control group. "There did not appear to be a significant learning curve for the [single-port] procedure," Wren and Curet wrote.
The presence of inflammation, seen in six of the nine patients included in the analysis, tended to prolong the procedure. Operating room time for the patients without inflammation was 82 to 88 minutes, whereas in two patients with empyema and hydrops the procedures took two hours or more.
The surgeon spent an average of just over one hour (range 38 to 99 minutes) at the operative console during the procedure.
Other tasks adding to operating room time included preparing the port (mean 17 minutes from skin incision to cannula insertion), docking the robotic arms (mean 5 minutes), and port removal and closure (mean 18 minutes).
No intraoperative complications were reported, and with follow-up ranging from five to 10 months, Wren and Curet saw no serious adverse events.
Two male patients had postoperative urinary retention requiring a urinary catheter during the first night. One was discharged with a catheter, which was removed a week later.
One patient in the control group developed atrial fibrillation, and two male patients had urinary retention, the researchers reported.
During the first few robotic procedures, there were two cases in which part of the access port device tore off as the specimen extraction bag was placed and the pieces needed to be retrieved. Wren and Curet indicated that they then revised their technique for inserting the specimen bag and the problem did not recur.
On a standard 10-point scale, patients rated pain at discharge with a mean score of 2.5. The mean score at a postoperative visit two to three weeks later was 0.67.
Asked their opinions 30 days after surgery, the robotic surgery patients told the researchers they were highly satisfied with the robotic surgery and would recommend it to others.
"The da Vinci single-site platform performed equivalently to traditional multiport cholecystectomy in this human use study," Wren and Curet wrote.
However, they noted, "additional trials would need to be performed to directly compare it with current single-port surgery."
The study had no external funding. Intuitive Surgical provided the instrumentation used in the study.
Wren reported serving as a consultant to Intuitive Surgical.
Curet reported serving as the company's chief medical advisor.
Primary source: Archives of Surgery
Wren S, et al "Single-port robotic cholecystectomy: results from a first human use clinical study of the new da Vinci single-site surgical platform" Arch Surg 2011; DOI: 10.1001/archsurg.2011.143.
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