OHTAC Recommendation

Transcription

1 OHTAC Recommendation Robotic-Assisted Minimally Invasive Surgery for Gynecologic and Urologic Oncology Presented to the Ontario Health Technology Advisory Committee in August 2010 December 2010

2 OHTAC Recommendation: Robotic-Assisted Minimally Invasive Surgery for Gynecologic and Urologic Oncology Issue Background An application was received to review the evidence on the The Da Vinci Surgical System for the treatment of gynecologic malignancies (e.g. endometrial and cervical cancers). Limitations to the current standard of care include the lack of trained physicians on minimally invasive surgery (e.g. conventional laparoscopy) and limited access to minimally invasive surgery for patients. The overall numbers of hysterectomies for cancer indications that are performed by laparoscopy are relatively few compared to open surgery. The potential benefits of The Da Vinci Surgical System include improved technical manipulation and physician uptake leading to increased surgeries, and treatment and management of these cancers. The demand for robotic surgery for the treatment and management of prostate cancer has been increasing due to its alleged benefits of recovery of erectile function and urinary continence, two important factors of men s health. The potential technical benefits of robotic surgery leading to improved patient functional outcomes are surgical precision and increased accuracy due to improved vision and instrument dexterity. Burden of Illness Uterine and cervical cancers represent 5.4% (4,400 of 81,700) and 1.6% (1,300 of 81,700), respectively, of incident cases of cancer among female cancers in Canada. Prostate cancer is ranked first in men in Canada in terms of the number of new cases among all male cancers (25,500 of 89,300 or 28.6%). OHTAC Findings The research questions of the MAS evaluation for both endometrial and cervical cancers were: 1. What is the effectiveness of the Da Vinci Surgical System vs. laparoscopy and laparotomy for women undergoing any hysterectomy for the surgical treatment and management of their endometrial and cervical cancers? 2. What are the incremental costs of the Da Vinci Surgical System vs. laparoscopy and laparotomy for women undergoing any hysterectomy for the surgical treatment and management of their endometrial and cervical cancers? For prostate cancer, 3. What is the effectiveness of robotically-assisted radical prostatectomy using the Da Vinci Surgical System vs. laparoscopic radical prostatectomy and retropubic radical prostatectomy for the surgical treatment and management of prostate cancer? 4. What are the incremental costs of robotically-assisted radical prostatectomy using the Da Vinci Surgical System vs. laparoscopic radical prostatectomy and retropubic radical prostatectomy for the surgical treatment and management of prostate cancer? Findings Published studies were heterogeneous in nature, perhaps due to the different types of observational studies identified. While statistical significance was shown in the meta-analysis, the clinical significance of certain outcomes is low due to the marginal benefit shown for robotic surgery. These subtleties are highlighted in the summary of findings shown below. 2

3 1. Robotic use for gynecologic oncology compared to: Laparotomy: benefits of robotic surgery in terms of shorter length of hospitalization and less blood loss. These results indicate clinical effectiveness in terms of reduced morbidity and safety, respectively, in the context of study design limitations. i. The beneficial effect of robotic surgery was shown in pooled analysis for complications, owing to increased sample size. ii. More work is needed to clarify the role of complications in terms of safety, including improved study designs, analysis and measurement. Laparoscopy: benefits of robotic surgery in terms of shorter length of hospitalization, less blood loss and fewer conversions to laparotomy likely owing to the technical difficulty of conventional laparoscopy, in the context of study design limitations. i. Clinical significance of significant findings for length of hospitalizations and blood loss is low. ii. Fewer conversions to laparotomy indicate clinical effectiveness in terms of reduced morbidity. 2. Robotic use for urologic oncology, specifically prostate cancer, compared to: Retropubic surgery: benefits of robotic surgery in terms of shorter length of hospitalization and less blood loss/fewer individuals requiring transfusions. These results indicate clinical effectiveness in terms of reduced morbidity and safety, respectively, in the context of study design limitations. There was a beneficial effect in terms of decreased positive surgical margins and erectile dysfunction. These results indicate clinical effectiveness in terms of improved cancer control and functional outcomes, respectively, in the context of study design limitations. i. Surgeon skill had an impact on cancer control and functional outcomes. ii. The results for complications were inconsistent when measured as either total number of complications, pain management or anastomosis. There is some suggestion that robotic surgery is safe with respect to less post-operative pain management required compared to retropubic surgery, however improved study design and measurement of complications need to be further addressed. iii. Clinical significance of significant findings for length of hospitalizations is low. Laparoscopy: benefits of robotic surgery in terms of less blood loss and fewer individuals requiring transfusions likely owing to the technical difficulty of conventional laparoscopy, in the context of study design limitations. i. Clinical significance of significant findings for blood loss is low. ii. The potential link between less blood loss, improved visualization and improved functional outcomes is an important consideration for use of robotics. 3. All studies included were observational in nature and therefore the results must be interpreted cautiously. 3

4 Decision Determinants OHTAC has developed a decision-making framework that consists of seven guiding principles for decision making and a decision-making tool, called the Decision Determinants (DD) tool. The evaluation of the four explicit main criteria (overall clinical benefit, value for money, feasibility of adoption into health system, and consistency with expected societal & ethical values) are reported in using 1 of 4 symbols. For more information on the Decision-Making Framework and the meaning of the symbols below, please refer to the Decision Determinants Guidance Document or visit: Gynecology Robotic vs. Open Overall clinical benefit Consistency with expected societal and ethical values Value for money Feasibility of adoption into the health system Prostate Cancer Robotic vs. Open Overall clinical benefit Consistency with expected societal and ethical values 4

5 Robotic vs. Open Value for money Feasibility of adoption into the health system OHTAC Recommendations Recognizing the low quality evidence for robotic-assisted minimally invasive surgery and its current diffusion OTHAC was unable to make a recommendation on the effectiveness of robotic-assisted laparoscopic radical/total hysterectomy or robotic-assisted laparoscopic radical prostatectomy at this time. However, OHTAC did recommend: For gynecology, Recognizing the rapid diffusion of this technology, OHTAC recommends a field evaluation using administrative datasets to address the residual uncertainty of this technology prior to definitive OHTAC recommendations regarding its wide adoption. In this context, OHTAC recommends that a subcommittee be formed to report back to OHTAC regarding the ongoing conduct of the field evaluation. For prostate cancer, Recognizing the rapid diffusion of this technology, OHTAC recommends a field evaluation to address the residual uncertainty of this technology prior to definitive decisions regarding its wide adoption. OHTAC recommends a subcommittee be formed and report back to OHTAC regarding the feasibility of undertaking a field evaluation that addresses relevant outcomes for prostate cancer including the complex measurement of erectile dysfunction and urinary incontinence. Surgical expertise is critical to maximize patient outcomes and minimize complication rates with the use of this technology. 5