Robot-assisted laparoscopic sacrocolpopexy does not get patients in and out of the operating room quicker than traditional laparoscopy does.
The study is the first randomized trial to compare robot-assisted laparoscopy and traditional laparoscopy in the field of gynecology and is the largest randomized trial comparing the two minimally invasive techniques in any surgical field to date, said lead investigator Marie Fidela R. Paraiso, MD, a urogynecologist at the Center for Specialized Women's Health at Cleveland Clinic.
Patients were included in the study if they were at least 21 years of age and had a post-hysterectomy vaginal apex prolapse at Pelvic Organ Prolapse Quantification stages two to four. They were comparable in their preoperative anatomic and functional data.
"The primary outcome of the trial was operative time [from incision to closure], and many other time parameters were measured as well," said Dr. Paraiso, who presented the findings at the 2010 joint meeting of the International Continence Society and International Urogynecological Association.
Investigators determined, a priori, that 32 subjects were needed to detect a difference of at least 30 minutes or more in operating time between the two arms that would reach a level of statistical significance with a p-value less than .05.
A total of 76 patients were enrolled, with 37 randomized to laparoscopic sacrocolpopexy and 39 randomized to robot-assisted sacrocolpopexy. Five patients withdrew from the conventional arm and four withdrew from the robot-assisted arm, mostly for personal reasons.
Investigators found that total operating time, as well as time under anesthesia and total suturing time, were all significantly greater in the robot-assisted arm (p<.0001).
In addition, there were no significant differences in the rates of complications, length of hospital stay, or use of pain medication while in the hospital.
Investigators also found that pain scores were comparable on day 1 following surgery and 1 week following surgery.
In addition, patients who underwent robot-assisted surgery had notably greater pain at rest and with activity during weeks 3 through 6 postoperatively. The median number of days that patients required narcotic pain medication was similar between the two arms. Patients who received non-conventional laparoscopic surgery used nonsteroidal anti-inflammatory drugs for a longer period of time than patients who received conventional surgery (19.5 vs. 9.5 days, p=.005).
Surgeon experience not a factor
Surgeons' level of experience did not have a bearing on surgical times. There was no significant association between the number of cases a surgeon performed and the surgical times that were recorded.
There was significant improvement in both arms in anatomic outcomes and quality of life but no difference between groups.
While it appears robot-assisted laparoscopic sacrocolpopexy is not cost-effective, Dr. Paraiso said that further analysis needs to be performed to conclude that definitively. The best measurements would include direct and indirect costs for the patient.
"We are looking at cost at the present time and will share our results soon," she said.
Dr. Paraiso said she and her co-investigators would likely conduct a longer-term follow-up study and examine when using the robot for this surgery would be advantageous. She concluded that robotic assistance has increased the adoption of minimally invasive sacrocolpopexy, but that it is not advantageous in the hands of surgeons who are expert conventional laparoscopists.