Robot assisted hysterectomy: A health technology assessment
Health technology assessment
|Published
The purpose of this health technology assessment was to investigate the clinical effects, and to conduct a health economic evaluation of robot assisted hysterectomy for individuals with endometrial cancer and benign conditions.
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Key message
This health technology assessment has summarized the evidence base on robot-assisted hysterectomy. We included nine studies that compared robot-assisted with conventional laparoscopic and/or open hysterectomy for endometrial cancer. No studies on benign endometrial conditions met our inclusion criteria.
We found that robot-assisted, compared to laparoscopic hysterectomy, may result in:
- Reduced operating time
- Small or no difference in blood loss
- Reduced 30-day mortality
- shorter hospital stay
We found that robot-assisted, compared to open hysterectomy, may result in:
- Reduced 30- and 90-day mortality
- shorter hospital stay
- Fewer readmissions
- Increased five-year survival
The results indicate possible benefits of robotic surgery for some outcomes, but the knowledge base is too weak to conclude definitively.
Costs associated with investment, consumables, and services were significantly higher for robot-assisted hysterektomi compared to laparoscopic and open hysterektomi. Based on the current information regarding effect and costs, it seems unlikely that robot-assisted surgery is a cost-effective alternative to laparoscopy. In comparison with open surgery, we could not draw conclusions regarding cost-effectiveness. There is a need for more, well-conducted studies for both benign and malignant indications. Cost-effectiveness should be reassessed when new studies on clinical efficacy become available.
Summary
Introduction
Hysterectomy involves surgical removal of the uterus. Hysterectomy is performed for gynaecological cancers, such as endometrial and cervical cancer of which endometrial cancer is the most common. Hysterectomy is also a treatment for benign conditions of which the most common are symptomatic fibroids in the uterus (myomas), bleeding disorders, pelvic pain, endometriosis, and uterine prolapse. Hysterectomy can be performed using four alternative surgical methods: open, vaginal, laparoscopic and robot-assisted hysterectomy. The use of robotic assisted surgery for hysterectomy is increasing. However, the clinical effectiveness and cost-effectiveness of using robotic hysterectomy has not yet been evaluated in the Norwegian context.
Objective
The purpose of this health technology assessment was to investigate the clinical effects, and to conduct a health economic evaluation of robot assisted hysterectomy for individuals with endometrial cancer and benign conditions. Robot-assisted hysterectomy was compared to open, conventional laparoscopic, and vaginal hysterectomy. In addition, we briefly highlight the organizational aspects of the initiative.
Method
We conducted a systematic literature search in relevant databases. Two project members individually screened titles, abstracts, and potentially relevant full-text articles against the inclusion criteria. One project member extracted and analysed data from the included studies, while another checked the data. Two team members assessed the risk of bias in the primary studies and evaluated the confidence in the results using GRADE. We performed a simplified health economic assessment, where we collected investment costs and costs per hospital stay for the relevant surgical alternatives. We gathered information on the organization of robotic surgery from clinical professional communities, and present examples from three Norwegian hospitals.
Results
We included three randomized and six non-randomized studies. The studies were conducted in Sweden, Finland, and the USA between 2015 and 2022. All the included studies focused on endometrial cancer and compared robot-assisted hysterectomy with laparoscopic or open hysterectomy. Disease stages and the proportion of patients who had lymph nodes removed varied across the studies. We did not find any studies on benign conditions nor any studies comparing robot-assisted and vaginal hysterectomy which fulfilled the inclusion criteria. We found that robot-assisted hysterectomy, compared to laparoscopy, may result in reduced operating time, little or no difference in blood loss, reduced 30-day mortality, and shorter hospital stays (Table 1). Based on available data, we have not been able to determine how robot-assisted hysterectomy affects intra- and postoperative complications, conversion to open surgery, postoperative pain, readmissions, or long-term survival compared to conventional laparoscopy. Compared with open surgery, robot-assisted hysterectomy may result in reduced 30- and 90-day mortality, shorter hospital stays, fewer readmissions, and increased five-year survival (Table 2). Based on available data, we have not been able to determine how robot-assisted hysterectomy affects intra- and postoperative complications, adverse events during and after hospitalization, blood loss, or operating time compared to open surgery. A summary of the results in which we have the highest confidence is presented in Tables 1 and 2.
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Table 1: Effects of robot assisted versus conventional, laparoscopic hysterectomy |
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Outcome |
Anticipated absolute effects (95% CI) |
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Laparoscopic |
Robot-assisted |
Relative effect (95% CI) |
Number of patients (studies) |
Certainty (GRADE) |
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|
Blood loss |
75 ml |
MD 4 ml lower |
- |
99 |
⨁⨁◯◯ |
|
30-day mortality |
7 per 1 000 |
2 fewer per 1 000 3 fewer to 0 fewer) |
RR 0.72 (0.52 to 0.99) |
30359 (1 non-RCT) |
⨁⨁◯◯ |
|
Operation time |
169 min. |
MD 37 min. shorter |
- |
99 |
⨁⨁◯◯ |
|
Length of hospital stay |
- |
MD 0.3 days shorter |
- |
2087 (1 non-RCT) |
⨁⨁◯◯ |
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CI: Confidence Interval; MD: Mean Difference; n: Number of Participants; RCT: Randomized Controlled Trial. We have downgraded the confidence in the effect estimates for: a. Uncertainties regarding the randomization process, b. One study with few participants, c. Wide CI crossing the line of no effect, d. High risk of bias * downgraded by 2 levels. |
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Table2: Effects of robot assisted versus open hysterectomy
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Outcome |
Anticipated absolute effects (95% CI) |
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Open |
Robot-assisted |
Relative effect (95% CI) |
Number of patients (studies) |
Certainty (GRADE) |
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|
30-day mortality |
12 per 1 000 |
7 fewer per 1 000 (8 fewer to 6 fewer) |
RR 0.42 |
34560 |
⨁⨁◯◯ |
|
90-day mortality |
23 per 1 000 |
11 fewer per 1 000 (13 fewer to 9 fewer) |
RR 0.52 |
34560 |
⨁⨁◯◯ |
|
Length of hospital stay (share with <2 days) |
397 per 1 000 |
472 more per 1 000 (461 more to 488 more |
RR 2.19 |
48985 |
⨁⨁◯◯ |
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Readmissions (30 and 90 d.) |
45 per 1 000 |
18 fewer per 1 000 (21 fewer to 16 fewer) |
RR 0.59 |
47297 |
⨁⨁◯◯ |
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Five-year survival |
- |
- |
HR 0.85 |
34588 (1 non-RCT) |
⨁⨁◯◯ |
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CI: Confidence Interval; MD: Mean Difference; n: Number of Participants; RCT: Randomized Controlled Trial. We have downgraded the confidence in the effect estimates for: a. High risk of bias * downgraded by 2 levels. |
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Investment costs and costs associated with disposable materials and service were significantly higher for robot-assisted surgery compared to traditional laparoscopy and open surgery. Excluding investment costs, the simplified cost assessment also indicated that robot-assisted hysterectomy was more expensive than laparoscopic hysterectomy. The costs per procedure for robot-assisted surgery was closely related to the volume of operations, where higher volume of operations resulted in lower costs. Although the cost per hospital stay (excluding investment costs), based on the cost per patient (KPP) model, showed that robot-assisted hysterectomy was lower than open surgery, there is considerable uncertainty associated with these data since they were not adjusted for differences in patient populations.
Robotic surgical systems were used for multiple indications at all three hospitals. The distribution of operation time across indications and the number of operations varied among the hospitals. Two of the hospitals used the same surgical team for robot-assisted and traditional surgery, whereas the third hospital replaced one of the two surgeons with a specially trained operating nurse during robot-assisted prostatectomy and hysterectomy.
Discussion
There is considerable uncertainty associated with the results. We consistently assessed the confidence in the effect estimates to be low or very low. The main reasons for downgrading confidence were the risk of systematic biases, and inconsistent and imprecise results. All included studies addressed endometrial cancer. None of the studies on benign indications met the inclusion criteria. Conclusively we cannot say anything about the effect of robot-assisted hysterectomy for benign indications based on this health technology assessment. It is challenging to evaluate a newer technology such as robot-assisted surgery against established techniques like traditional laparoscopy and open surgery. Although we excluded studies with surgeons in a learning phase, it is conceivable that less experience with robot-assisted technique could have influenced the results.
Since we have not been able to document certainty regarding in health effects that necessitate a model-based health economic evaluation, we conducted a simplified cost assessment for the relevant surgical methods. For hospital stays, we reported national average KPP. A significant limitation of KPP is that we have not been able to adjust for differences in patient populations who received the different surgical techniques. There are no national procurements of robotic surgery systems, so individual hospitals and regional health authorities have made their own purchases. We have presented prices from confidential historical acquisitions from the South-Eastern Norway Regional Health Authority, since investment costs are not included in KPP. However, these costs were based on offers from a single supplier. From 2024, more suppliers are expected to enter the market, and procurement prices may change.
Conclusion
The results indicate possible benefits of robot-assisted hysterectomy compared to laparoscopy and open surgery, but the knowledge base is too weak to conclude with certainty. Costs related to investment, consumables, and service were significantly higher for robot-assisted surgery than for traditional laparoscopy and open surgery. Excluding investment costs, the cost per hospital stay was higher for robot-assisted hysterectomy than laparoscopy. However, costs per hospital stay are not adjusted for possible differences in patient population Based on the current information regarding effect and costs, it seems unlikely that robot-assisted surgery is a cost-effective alternative to laparoscopy. We could not conclude regarding the cost-effectiveness with comparison to open surgery. There is a need for more well-conducted studies on robot-assisted hysterectomy, for both benign and malignant indications. Cost-effectiveness should be reassessed when new studies on clinical efficacy are available.
