Original Title: Robotassistert hysterektomi

Authors' objectives: 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.

Authors' results and conclusions: 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. 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.

Authors' methods: 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.

Project Status: Completed

URL for project: https://www.fhi.no/en/cristin-projects/ongoing/robotic-hysterectomy---protocol-for-a-health-tech-nology-assessment/

Year Published: 2024

URL for published report: https://www.fhi.no/en/publ/2024/Robot-assisted-hysterectomy/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo