Swiss Medical Board published two reports on robot-assisted laparoscopic surgery

11

Apr 2019

Swiss Medical Board is a private entity, set up by the Cantons, Swiss Medical Association (FMH), Swiss Academy of Medical Sciences and insurers’ associations (santésuisse and curafutura), whose importance keeps growing and that is trying to improve the quality of the HTA in Switzerland.

On March 15, 2019, they published two appraisal reports: “Robot-assisted laparoscopic surgery versus open surgery for radical prostatectomy” and “Robot-assisted laparoscopic surgery versus conventional laparoscopic surgery for simple or radical hysterectomy.”

Cancer of the prostate and cancer of the female reproductive organs are common diseases and a frequent cause of cancer-related death in Switzerland. In men, radical prostatectomy (i.e., surgical removal of the prostate gland, both seminal vesicles, and a portion of both vas deferens) is a treatment option for patients with localized cancer and can be performed as an open or minimally invasive laparoscopic surgery, with or without support by a robot system. In women, removal of the uterus with or without its adnexa (i.e., radical or simple hysterectomy) is indicated for both benign and malignant conditions. Hysterectomy can be performed by an open abdominal, open vaginal, or minimally invasive laparoscopic approach. Laparoscopic interventions may be supported by a robot system, or not.

The appraisal report compares the effectiveness, safety, and cost-utility of the robot-assisted technique with those of the conventional methods, i.e., open radical prostatectomy (ORP) and conventional laparoscopic hysterectomy (CLH). As of July 2018, a total of 33 robot systems existed in Swiss hospitals; all were DaVinci® robots with an approximate purchase price of CHF 1.8 million each.

Robot-assisted radical laparoscopic prostatectomy

Based on evidence from one randomized controlled trial (n=326), robot-assisted radical prostatectomy (RARP) likely resulted in little to no difference in urinary tract function when compared to retropubic open radical prostatectomy (ORP) (mean difference [MD] -1.30, 95% CI -4.65 to 2.05, with minimal clinically significant difference [MCID] = 6 points). Furthermore, RARP did not appear to result in any significant difference in sexual function (MD 3.90, 95% CI -1.84 to 9.64 with MCID = 10 points). RARP reduced the length of hospital stay (LOS) by one or two days (MD -1.72 days, 95% CI -2.19 to -1.25 with MCID = 1 day). In addition, RARP did not appear to be associated with any difference in the need for blood transfusions (RR 0.16, 95% CI 0.02 to 1.32). The Appraisal Committee concluded that the differences in efficacy between RARP and ORP were small in the study included in the assessment.

Based on the same RCT, RARP appeared to result in some reduction in postoperative pain as compared to ORP after one day (MD -1.15; 95% CI 1.68 to -0.62) and after one week (MD -1.13; 95% CI -1.65 to -0.61). However, there seemed to be little or no difference in postoperative pain after 12 weeks (MD 0.01, 95% CI -0.32 to 0.34). In addition, RARP appeared to result in little to no reduction of surgical (intra- and perioperative) complications of any severity (RR 0.41, 95%CI 0.16 to 1.04) and of serious postoperative complications (RR 0.16, 95% CI 0.02 to 1.32) although the point estimates suggested that RARP may have the potential to reduce these undesirable effects. The Appraisal Committee concluded that the differences in safety between RARP and ORP were moderate.

The overall quality of the evidence was judged as low.

The balance between benefits and harm was judged differently for outcomes in the short term and the long run. The Appraisal Committee deemed that the balance between desirable and undesirable effects probably favors RARP for short-term outcomes, while for long-term outcomes the balance does no longer favor RARP.

Regarding the de novo cost analysis, the Appraisal Committee concluded that the additional resource requirements for RARP (as compared to ORP) are moderate and would become smaller if the use of RARP was centralized in fewer centers. Furthermore, taking into account the cost analysis with its assumptions and limitations, the Appraisal Committee concluded that the current practice of using RARP also in hospitals with small caseload does not favor its use compared to ORP. RARP would become cost-effective only if the number of hospitals using robot-assisted surgery was reduced.

Robot-assisted laparoscopic hysterectomy

The evidence of clinical effectiveness and harm of robot-assisted hysterectomy (RAH) was based on six randomized controlled trials involving a total of 632 participants. In one trial, RAH showed no difference in postoperative pain when compared to conventional laparoscopic hysterectomy (CLH). The mean difference was -2.00 (95% CI -16.08 to 12.08), but the pain scale (range) was not reported. Moreover, data covered interventions for benign conditions only.

In a single study in patients with endometrial cancer comparing RAH and CLH, no deaths in either treatment group occurred. Neither this nor any other study reported disease-free survival times. The evidence from two studies in benign conditions suggests small gains in quality of life in favor of RAH although data could not be pooled.

RAH may have reduced LOS by less than one day (MD -0.30 day, 95% CI -0.53 to -0.07; MCID = 1 day). It remained uncertain whether RAH led to a reduction of total operating time; the mean difference between RAH and CLH was 41.18 min with 95% CI ranging from -6.17 to 88.53 min. Both these estimates were from two studies in benign conditions only. The Appraisal Committee concluded that differences in efficacy between RAH and CLH were negligible.

Intra- and postoperative complications after RAH and CLH were comparable; relative risk (RR) associated with RAH was 0.76 (95% CI 0.38 to 1.53) in benign conditions and 1.47 (95% CI 0.79 to 2.72) in endometrial cancer. When compared to CLH, RAH may have led to a higher risk of needing blood transfusions in benign conditions (RR 1.94; 95% CI 0.30 to 12.76) as well as in endometrial cancer (RR 2.94; 95% CI 0.62 to 13.87). None of the differences reached statistical significance.

The Appraisal Committee concluded that the overall quality of evidence was low.

The Assessment Committee concluded that the available evidence for RAH probably does not favor either the robot-assisted or the conventional laparoscopic technique for hysterectomy.

Regarding the de novo cost analysis, the Appraisal Committee concluded the additional resource requirements for RAH as compared to CLH to be moderate. Furthermore, taking into account the presented economic analysis, the Appraisal Committee found that the evidence of cost-utility favors the use of conventional laparoscopic surgery for both simple and radical hysterectomy.

Other conclusions by the Appraisal Committee:

  • The available evidence suggests that patient perception of potential benefits or harm associated with robot-assisted surgery varies only minimally from those associated with open surgery (for prostatectomy) or conventional laparoscopic surgery (for hysterectomy). However, differences between subgroups may exist depending on patient age or the presence of co-morbidities
  • The choice between robot-assisted and conventional surgery for prostatectomy and hysterectomy does not impact on health equity
  • From the patients’ perspective, RARP is probably favored (also because the alternative is not minimally invasive), and RAH may or may not be favored (because the alternative is minimally invasive). From the surgeons’ perspective, robot-assisted technology seems to be favored only if the operating team is highly experienced thus ensuring controlled duration of the intervention
  • The feasibility of robot-assisted surgery is no longer a matter of debate. This does not preclude a discussion about its economic sustainability in the long term and possibilities to optimize the use of the existing robot systems in the centers. In particular, caseloads that are too small to justify the initial investment and that may drive unwarranted broadening of the clinical indication should be avoided.

See the full news and the report in English (change to German or French in the top-right corner) here.

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