Robotic-assisted minimally invasive surgery for gynecologic and urologic oncology: an evidence-based analysis.

OBJECTIVE: 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 and limited access to minimally invasive surgery for patients. 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 vision.

CLINICAL NEED: 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. Uterine cancer, otherwise referred to as endometrial cancer is cancer of the lining of the uterus. The most common treatment option for endometrial cancer is removing the cancer through surgery. A surgical option is the removal of the uterus and cervix through a small incision in the abdomen using a laparoscope which is referred to as total laparoscopic hysterectomy. Risk factors that increase the risk of endometrial cancer include taking estrogen replacement therapy after menopause, being obese, early age at menarche, late age at menopause, being nulliparous, having had high-dose radiation to the pelvis, and use of tamoxifen. Cervical cancer occurs at the lower narrow end of the uterus. There are more treatment options for cervical cancer compared to endometrial cancer, however total laparoscopic hysterectomy is also a treatment option. Risk factors that increase the risk for cervical cancer are multiple sexual partners, early sexual activity, infection with the human papillomavirus, and cigarette smoking, whereas barrier-type of contraception as a risk factor decreases the risk of cervical cancer. 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%). The impact on men who develop prostate cancer is substantial given the potential for erectile dysfunction and urinary incontinence. Prostate cancer arises within the prostate gland, which resides in the male reproductive system and near the bladder. Radical retropubic prostatectomy is the gold standard treatment for localized prostate cancer. Prostate cancer affects men above 60 years of age. Other risk factors include a family history of prostate cancer, being of African descent, being obese, consuming a diet high in fat, physical inactivity, and working with cadium. THE DA VINCI SURGICAL SYSTEM: The Da Vinci Surgical System is a robotic device. There are four main components to the system: 1) the surgeon's console, where the surgeon sits and views a magnified three-dimensional image of the surgical field; 2) patient side-cart, which sits beside the patient and consists of three instrument arms and one endoscope arm; 3) detachable instruments (endowrist instruments and intuitive masters), which simulate fine motor human movements. The hand movements of the surgeon's hands at the surgeon's console are translated into smaller ones by the robotic device and are acted out by the attached instruments; 4) three-dimensional vision system: the camera unit or endoscope arm. The main advantages of use of the robotic device are: 1) the precision of the instrument and improved dexterity due to the use of "wristed" instruments; 2) three-dimensional imaging, with improved ability to locate blood vessels, nerves and tissues; 3) the surgeon's console, which reduces fatigue accompanied with conventional laparoscopy surgery and allows for tremor-free manipulation. The main disadvantages of use of the robotic device are the costs including instrument costs ($2.6 million in US dollars), cost per use ($200 per use), the costs associated with training surgeons and operating room personnel, and the lack of tactile feedback, with the trade-off being increased visual feedback.

RESEARCH QUESTIONS: For endometrial and cervical cancers, 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?

RESEARCH METHODS: A literature search was performed on May 12, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, Wiley Cochrane, CINAHL, Centre for Reviews and Dissemination/International Agency for Health Technology Assessment for studies published from January 1, 2000 until May 12, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.

INCLUSION CRITERIA: English language articles (January 1, 2000-May 12, 2010)Journal articles that report on the effectiveness or cost-effectiveness for the comparisons of interest using a primary data source (e.g. obtained in a clinical setting)Journal articles that report on the effectiveness or cost-effectiveness for the comparisons of interest using a secondary data source (e.g. hospital- or population-based registries)Study design and methods must be clearly describedHealth technology assessments, systematic reviews, randomized controlled trials, non-randomized controlled trials and/or cohort studies, case-case studies, regardless of sample size, cost-effectiveness studies

EXCLUSION CRITERIA: Duplicate publications (with the more recent publication on the same study population included)Non-English papersAnimal or in-vitro studiesCase reports or case series without a referent or comparison groupStudies on long-term survival which may be affected by treatmentStudies that do not examine the cancers (e.g. advanced disease) or outcomes of interest

OUTCOMES OF INTEREST: For endometrial and cervical cancers, Primary outcomes: Morbidity factors- Length of hospitalization- Number of complicationsPeri-operative factors- Operation time- Amount of blood loss- Number of conversions to laparotomyNumber of lymph nodes recoveredFor prostate cancer, Primary outcomes: Morbidity factors- Length of hospitalization- Amount of morphine use/painPeri-operative factors- Operation time- Amount of blood loss- Number of transfusions- Duration of catheterization- Number of complications- Number of anastomotic stricturesNumber of lymph nodes recoveredOncologic factors- Proportion of positive surgical marginsLong-term outcomes- Urinary continence- Erectile function

SUMMARY OF FINDINGS: 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.The beneficial effect of robotic surgery was shown in pooled analysis for complications, owing to increased sample size.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.Clinical significance of significant findings for length of hospitalizations and blood loss is low.Fewer conversions to laparotomy indicate clinical effectiveness in terms of reduced morbidity.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.Surgeon skill had an impact on cancer control and functional outcomes.The results for complications were inconsistent when measured as either total number of complications, pain management or anastomosis. (ABSTRACT TRUNCATED)