Robot-assisted surgery in thoracic and visceral indications assessed in Austria

In early May 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment on robot-assisted surgery in thoracic and visceral indications as part of the EUnetHTA work.

The project was executed by the LBI, Austrian Johanneum Research and HTA unit of Italian Veneto region, as co-authors. The dedicated reviewers come from the Health Information and Quality Authority, Ireland and Social & Health Services and Labour Market, Denmark. 

Robotic surgery is a form of minimally invasive surgery whereby the instruments of the robotic system are controlled by a telemanipulator, which is a device for transmitting hand and finger movements to a remote robotic device, allowing the sequential manipulation of objects. The robot has a higher degree of dexterity compared to the laparoscopic approach, which enables surgeons to operate in very tight spaces in the body (which would otherwise only be accessible through open surgery) with the rationale of improving clinical outcomes and resource use.

There are 22 systems that have been developed, of which 13 are still in development, 7 are currently commercially available (da Vinci SI®, da Vinci SP®, da Vinci XI®, da Vinci X®, Freehand v1.2, Surgenius Beta and SenhanceTM Surgical System), 1 is available for research purposes only and 1 is only for the transoral and transanal approach. The evidence suggests that robot-assisted surgery is more expensive than conventional surgical methods.

The aim of this HTA report was to assess the effectiveness and safety of robot-assisted surgery in the area of thoracic and visceral indications. Thoracic procedures that were examined in the review included, in accordance with the project plan, pulmonary lobectomy, lung segmentectomy, and mediastinal surgery. Visceral procedures that were included in the review, in accordance with the project plan, were anti-reflux surgery/fundoplication, oesophagectomy or oesophageal repair, heller myotomy, gastrectomy, bariatric surgery, small bowel resection, colectomy, rectal resection, cholecystectomy, liver resection/hepatectomy, and hernia repair.

To identify primary studies fulfilling the inclusion criteria, a systematic literature search in the following databases was performed on the following databases: The Cochrane CENTRAL Register of Controlled, Embase (via Elsevier) and Ovid Medline. The following clinical trial databases were searched to identify ongoing studies: ClincalTrials.gov, EU Clinical Trials Register (EU-CTR), and The WHO International Clinical Trials Registry Platform (ICTRP). Clinical Practice Guidelines (CPGs) were searched in the UptoDate database.

Randomized controlled studies (RCTs) with ≥ 10 patients were used for assessing the evidence in the effectiveness and safety domains. If no relevant RCTs could be identified, prospective nonrandomized controlled studies with ≥ 10 patients were included. Perioperative outcomes and resource use were also considered. Potentially relevant studies according to study design were therefore included if they provided results on effectiveness, safety, or perioperative events/resource use outcomes. Comparators were laparoscopic surgery or open surgery. There were no restrictions on patient populations; all studies on patients with indications for thoracic or visceral surgery were included.

Results – Available evidence:

The systematic literature search did not identify any RCTs relating to thoracic surgery. Non-randomized controlled studies (3 for lobectomy/segmentectomy and 1 for mediastinal surgery) were included as the next best evidence level. Regarding visceral surgery, and specifically, surgery in the area of the oesophagus, 5 RCTs (6 publications) were identified relating to the procedure antireflux/fundoplication and oesophagectomy. For Heller myotomy, no RCTs were found, hence non-randomized, controlled studies were included (2 in total). Three RCTs were included relating to stomach surgery (2 for gastrectomy and 1 for bariatric surgery) and 7 RCTs were identified relating to bowel procedures (specifically 1 RCT for colectomy, 1 RCT for rectopexy and 5 RCTs for rectal resection). Lastly, in the area of gallbladder/liver/spleen, 4 RCTS were included for the cholecystectomy procedure whilst for liver resection and hernia repair, no RCTS could be identified thus again non-randomised, controlled studies were included (2 for liver resection and 1 for hernia repair).

Results – Clinical effectiveness and safety:

The diverse range of surgeries included in this review, combined with the lack of reliable evidence for almost all indications, poses difficulties for the analysis and reporting of results

• Oesophagectomy: robot-assisted surgery probably improves postoperative morbidity/QoL and reduces postoperative complications compared to open surgery (evidence quality: moderate). Intra-operative complications may be reduced with robot-assisted surgery vs. open surgery, but here the evidence quality is low.
• Gastrectomy: robot-assisted surgery may reduce postoperative complications vs. conventional laparoscopy (evidence quality: low)
• Rectal resection: robot-assisted surgery may improve sexual functioning but worsen sleep disturbances compared with traditional laparoscopy (evidence quality: low); robot-assisted surgery may decrease postoperative complications between 30 days and 6 months, but increase intraoperative complications (evidence quality: low)
•  Cholecystectomy: robot-assisted surgery may reduce intraoperative complications and postoperative complications at 30 days compared to laparoscopy (evidence quality: low)

For all other outcomes and procedures, the effect of robot-assisted surgery compared to open or laparoscopic surgery on the basis of the included study pool was either uncertain (we are uncertain whether robot-assisted surgery improves or reduces the outcome as the quality/certainty of the evidence has been assessed as very low), unknown (although included as an outcome in the study, relative effect could not be calculated as the study provided no information about the relative probability of the event, mainly due to missing events in one arm) or the available evidence did not measure the outcome.

Results – research in progress

The search within clinical trials databases identified many ongoing or planned trials on the use of robotic surgery in the field of thoracic and visceral surgery. However, not all the indications/procedures considered in this assessment were found to have ongoing trials, for instance, none could be identified for mediastinal surgery, Heller myotomy/oesophageal repair, bariatric surgery or small bowel resection.

Conclusions:

For 9 of the 13 procedures within the area of thoracic and visceral surgery that were considered in this HTA, the authors conclude that there is insufficient evidence on which a judgment can be made about the relative merits of robot-assisted surgery compared to the alternatives (mostly conventional laparoscopic procedures).

For four of the procedures, there was evidence on some of the outcomes, but not all. Of the outcomes for which there is evidence authors report that when compared with open surgery in oesophagectomy, robot-assisted surgery probably (evidence quality: moderate) has advantages in terms of QoL and postoperative complications (although this was not shown for the comparison with open gastrectomy); when compared with laparoscopic gastrectomy, there may be advantages in terms of postoperative complications with the use of robot-assisted surgery. There is some low-quality evidence that robot-assisted cholecystectomy may confer benefits in terms of reduced complications. The evidence for robot-assisted rectal resection was mixed with some areas of improvement and some areas of a decline regarding QoL outcomes and some reduced post-operative complications but some increased intraoperative complications.

For several procedures, only a single (or no) RCT was available; here, further studies are necessary.

Limitations of the present report include the lack of stratification according to surgical experience. In addition, an analysis of the number of cases required to maintain training and knowledge related to the method would be useful. Extensive, highly specialized training and an adequate volume of cases are required for surgeons and their surgical teams to maintain proficiency. A further limitation related to the decision to include only RCTs with more than 10 patients where these are available, to the exclusion of other types of evidence. However, it should be noted that the conclusions drawn here are generally in accordance with systematic reviews and meta-analyses results of observational studies.

See the report in English here.

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