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Robotic Prostatectomy Delivers on the Promise of Minimally Invasive Surgery
Accepted Manuscript Title: Robotic Prostatectomy Delivers on the Promise of Minimally Invasive Surgery. Author: Kamran Zargar-Shoshtari, Nathan Lawrentschuk, Homayoun Zargar PII: DOI: Reference:
S0090-4295(16)30698-7 http://dx.doi.org/doi: 10.1016/j.urology.2016.10.001 URL 20064
To appear in:
Urology
Please cite this article as: Kamran Zargar-Shoshtari, Nathan Lawrentschuk, Homayoun Zargar, Robotic Prostatectomy Delivers on the Promise of Minimally Invasive Surgery., Urology (2016), http://dx.doi.org/doi: 10.1016/j.urology.2016.10.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Robotic
prostatectomy
delivers
on
the
promise
of
minimally
invasive surgery. Commentary on Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study Yaxley JW, Coughlin GD, Chambers SK, et al Lancet 2016 Kamran Zargar-Shoshtari1, Nathan Lawrentschuk2, Homayoun Zargar3 1-Division of Urology, Department of Surgery, University of Auckland, Auckland, New Zealand 2-Division
of
Cancer
Surgery,
Peter
MacCallum
Cancer
Centre,
University of Melbourne, Melbourne, Australia; Department of Surgery, Olivia Newton-John Cancer Research Institute, Austin Health, Melbourne, Australia 3- Department of Urology, Royal Melbourne Hospital, Melbourne, Australia; Australian Prostate Cancer Research Centre, Melbourne, VIC, Australia; University of Melbourne, Melbourne, Australia Corresponding Author: Homayoun Zargar Royal Melbourne Hospital 300 Grattan Street Parkville 3052 Victoria, Australia Email: [email protected] Keywords: robot-assisted, laparoscopic prostatectomy, radical retropubic prostatectomy SUMMARY: Yaxley et al recently reported the results of the first randomized clinical trial comparing early outcomes of men treated with robot-assisted 1
Page 1 of 4
laparoscopic prostatectomy (RARP) to open radical retropubic prostatectomy (ORP).1 Men aged 35-70 years with localized prostate cancer, PSA<20ng/ml, and no previous laparoscopic hernia repair, major pelvic surgery or radiation, were randomized to receive RARP or ORP. There was one primary surgeon in each arm; RARP by a surgeon with 200 case experience and ORP by a surgeon with 1500 case experience. Primary outcomes were urinary function (urinary domain of Expanded Prostate Cancer Index Composite [EPIC]) and sexual function (sexual domain of EPIC). Four hundred patients were to be recruited; however after interim analysis and recruitment of 321 patients, the study was closed on recommendation of the independent data committee, blinded to the study groups. The RARP group included 157 patients and the ORP arm consisted of 151 patients. EPIC Urinary function scores and EPIC sexual function scores did not differ between the ORP and RARP groups at 6 and 12 weeks. Operative time was shorter for RARP by 32 minutes (p<0.001). There were fewer intraoperative adverse events for the RARP patients (8% vs. 2%, p=0.02). There was less blood loss by an average of 895 mls (p<0.001) in favour of the RARP. The length of hospital stay was less by 1.7 days (p<0.001) with a trend for fewer post-operative adverse events for the RARP group (9% vs. 4%, p=0.051). Patients receiving RARP reported significantly lower pain and pain during activity at 1 day and 1 week following surgery (p=0.002). At 6 weeks, the RARP patients reported superior physical quality of life compared to the ORP patients. It was also reported that at 12 weeks ORP had higher Hospital Anxiety and Depression Scale (HADS) score with the ORP patients being significantly more distressed at 12 weeks compared to the RARP group (5.26 vs. 7.03, p=0.04). Time to return to work was similar between the two groups at 42.71 days for each arm. Pathological outcomes were also similar, although more lymph nodes were removed in the RARP group (6.5 vs. 3.2, p=0.004). COMMENT: Although RARP and ORP produced similar early outcomes when assessing the primary endpoints of urinary and sexual scores, there were many other
2
Page 2 of 4
areas in which RARP outperformed ORP. These included blood loss, operative time, operative adverse events, hospital stay, and pain. Considering the reported difference in the baseline procedure experience of the surgeons, it can be considered that robotic assisted surgery overcame 15 years and nearly 1300 case experience and accomplished similar outcomes in the primary endpoints and improved the results in many other areas. However, the competency of a surgeon depends on other factors than just surgical numbers and the results of this trial show competency is not an issue with either surgeon. The apparent lesser experience of the robotic surgeon is countered by fellowship training in a high volume center that is likely to have “evened-up” the experience. The mean operating blood loss for the ORP group was 1.3 L with nonstatistically significant higher blood transfusion rate (4% vs. 1%) in favour of RARP. Authors reported routine use of cell saver autologous blood recovery system during ORP. As this is not the standard of care in many centers, it is probable that the observed differences in estimated blood loss may render higher transfusion rates in the real-world practice. The pad use data at 12 weeks showed that only 6% of the ORP group and 10% of the RARP group used more than 1 pad per day, which reveals outstanding outcomes in the ORP patients. These results are comparable with some of the best published outcomes for the open approach.
2,3
Similarly, the
outcomes from RARP during the learning curve for this procedure may not mirror the results reported in this study and this is another important element to consider when analyzing the results of this trial. Interestingly neither group used pelvic floor physiotherapy as this was not part of the study protocol. The longer-term outcomes of the study are yet to be reported and oncological, functional and complication outcomes in particular bladder neck stricture rates are also worthy of detailed future examination. Overall this study demonstrated that RARP and ORP had comparable EPIC urinary and sexual scores at 6 and 12 weeks and improved outcomes for RARP were observed in many of the secondary endpoints. We conclude that the surgeon is the key element affecting the outcomes of radical prostatectomy. However based on the secondary outcomes of this trial it is suggested that the robotic platform may allow a surgeon to obtain the 3
Page 3 of 4
same functional and oncological outcomes as open surgery, but with the advantage of less post-operative pain, lower risk of blood loss, less perioperative complications, better physical health at 6 weeks and less emotional distress at 3 months post-surgery. Whether robot surgery will shorten the learning curve will need to be confirmed in other prospective trials.
References 1. Yaxley JW, Coughlin GD, Chambers SK, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet 2016. 2. Touijer K, Eastham JA, Secin FP, et al. Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005. J Urol 2008;179:1811-7; discussion 7. 3. Walsh PC, Marschke P, Ricker D, Burnett AL. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. Urology 2000;55:58-61.
4
Page 4 of 4
S0090-4295(16)30698-7 http://dx.doi.org/doi: 10.1016/j.urology.2016.10.001 URL 20064
To appear in:
Urology
Please cite this article as: Kamran Zargar-Shoshtari, Nathan Lawrentschuk, Homayoun Zargar, Robotic Prostatectomy Delivers on the Promise of Minimally Invasive Surgery., Urology (2016), http://dx.doi.org/doi: 10.1016/j.urology.2016.10.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Robotic
prostatectomy
delivers
on
the
promise
of
minimally
invasive surgery. Commentary on Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study Yaxley JW, Coughlin GD, Chambers SK, et al Lancet 2016 Kamran Zargar-Shoshtari1, Nathan Lawrentschuk2, Homayoun Zargar3 1-Division of Urology, Department of Surgery, University of Auckland, Auckland, New Zealand 2-Division
of
Cancer
Surgery,
Peter
MacCallum
Cancer
Centre,
University of Melbourne, Melbourne, Australia; Department of Surgery, Olivia Newton-John Cancer Research Institute, Austin Health, Melbourne, Australia 3- Department of Urology, Royal Melbourne Hospital, Melbourne, Australia; Australian Prostate Cancer Research Centre, Melbourne, VIC, Australia; University of Melbourne, Melbourne, Australia Corresponding Author: Homayoun Zargar Royal Melbourne Hospital 300 Grattan Street Parkville 3052 Victoria, Australia Email: [email protected] Keywords: robot-assisted, laparoscopic prostatectomy, radical retropubic prostatectomy SUMMARY: Yaxley et al recently reported the results of the first randomized clinical trial comparing early outcomes of men treated with robot-assisted 1
Page 1 of 4
laparoscopic prostatectomy (RARP) to open radical retropubic prostatectomy (ORP).1 Men aged 35-70 years with localized prostate cancer, PSA<20ng/ml, and no previous laparoscopic hernia repair, major pelvic surgery or radiation, were randomized to receive RARP or ORP. There was one primary surgeon in each arm; RARP by a surgeon with 200 case experience and ORP by a surgeon with 1500 case experience. Primary outcomes were urinary function (urinary domain of Expanded Prostate Cancer Index Composite [EPIC]) and sexual function (sexual domain of EPIC). Four hundred patients were to be recruited; however after interim analysis and recruitment of 321 patients, the study was closed on recommendation of the independent data committee, blinded to the study groups. The RARP group included 157 patients and the ORP arm consisted of 151 patients. EPIC Urinary function scores and EPIC sexual function scores did not differ between the ORP and RARP groups at 6 and 12 weeks. Operative time was shorter for RARP by 32 minutes (p<0.001). There were fewer intraoperative adverse events for the RARP patients (8% vs. 2%, p=0.02). There was less blood loss by an average of 895 mls (p<0.001) in favour of the RARP. The length of hospital stay was less by 1.7 days (p<0.001) with a trend for fewer post-operative adverse events for the RARP group (9% vs. 4%, p=0.051). Patients receiving RARP reported significantly lower pain and pain during activity at 1 day and 1 week following surgery (p=0.002). At 6 weeks, the RARP patients reported superior physical quality of life compared to the ORP patients. It was also reported that at 12 weeks ORP had higher Hospital Anxiety and Depression Scale (HADS) score with the ORP patients being significantly more distressed at 12 weeks compared to the RARP group (5.26 vs. 7.03, p=0.04). Time to return to work was similar between the two groups at 42.71 days for each arm. Pathological outcomes were also similar, although more lymph nodes were removed in the RARP group (6.5 vs. 3.2, p=0.004). COMMENT: Although RARP and ORP produced similar early outcomes when assessing the primary endpoints of urinary and sexual scores, there were many other
2
Page 2 of 4
areas in which RARP outperformed ORP. These included blood loss, operative time, operative adverse events, hospital stay, and pain. Considering the reported difference in the baseline procedure experience of the surgeons, it can be considered that robotic assisted surgery overcame 15 years and nearly 1300 case experience and accomplished similar outcomes in the primary endpoints and improved the results in many other areas. However, the competency of a surgeon depends on other factors than just surgical numbers and the results of this trial show competency is not an issue with either surgeon. The apparent lesser experience of the robotic surgeon is countered by fellowship training in a high volume center that is likely to have “evened-up” the experience. The mean operating blood loss for the ORP group was 1.3 L with nonstatistically significant higher blood transfusion rate (4% vs. 1%) in favour of RARP. Authors reported routine use of cell saver autologous blood recovery system during ORP. As this is not the standard of care in many centers, it is probable that the observed differences in estimated blood loss may render higher transfusion rates in the real-world practice. The pad use data at 12 weeks showed that only 6% of the ORP group and 10% of the RARP group used more than 1 pad per day, which reveals outstanding outcomes in the ORP patients. These results are comparable with some of the best published outcomes for the open approach.
2,3
Similarly, the
outcomes from RARP during the learning curve for this procedure may not mirror the results reported in this study and this is another important element to consider when analyzing the results of this trial. Interestingly neither group used pelvic floor physiotherapy as this was not part of the study protocol. The longer-term outcomes of the study are yet to be reported and oncological, functional and complication outcomes in particular bladder neck stricture rates are also worthy of detailed future examination. Overall this study demonstrated that RARP and ORP had comparable EPIC urinary and sexual scores at 6 and 12 weeks and improved outcomes for RARP were observed in many of the secondary endpoints. We conclude that the surgeon is the key element affecting the outcomes of radical prostatectomy. However based on the secondary outcomes of this trial it is suggested that the robotic platform may allow a surgeon to obtain the 3
Page 3 of 4
same functional and oncological outcomes as open surgery, but with the advantage of less post-operative pain, lower risk of blood loss, less perioperative complications, better physical health at 6 weeks and less emotional distress at 3 months post-surgery. Whether robot surgery will shorten the learning curve will need to be confirmed in other prospective trials.
References 1. Yaxley JW, Coughlin GD, Chambers SK, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet 2016. 2. Touijer K, Eastham JA, Secin FP, et al. Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005. J Urol 2008;179:1811-7; discussion 7. 3. Walsh PC, Marschke P, Ricker D, Burnett AL. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. Urology 2000;55:58-61.
4
Page 4 of 4