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Robotic-assisted surgery

NIHR Signal Robotic surgery for rectal cancer produces similar results to keyhole surgery

Published on 26 November 2019

doi: 10.3310/signal-000845

Robotic rectal cancer surgery does not appear technically easier than standard keyhole surgery. The researchers, in this trial, judged this by measuring the need to ‘convert’ a keyhole procedure to open surgery when operating. This NIHR-funded trial also found that robotic surgery produced similar clinical results to standard laparoscopic (keyhole) surgery in treating rectal cancer.

In the trial, 28 out of 230 patients (12%) who received keyhole surgery were converted to open surgery, compared with 19 out of 236 (8%) who received robotic surgery. This difference did not achieve statistical significance. There were also no differences in the likelihood of removing the whole tumour, surgery-related complications and bladder or sexual function. Longer-term outcomes such as three-year recurrence and overall survival were also similar.

These results suggest robotic rectal surgery, which costs £1,000 more than laparoscopic surgery due to ongoing equipment costs and longer operating time, may not be cost-effective.

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Why was this study needed?

There were 9,614 cases of rectal cancer in England in 2017. It is more common in older people, with most cases occurring after the age of 60. Data between 2013 and 2017 shows more than 80% survive for at least one year after diagnosis and 60% survive for at least five years.

Surgery is the most common treatment for rectal cancer and a number of techniques may be used. Open surgery requires the surgeon to make a large cut in the abdomen and sometimes the perineum to access the rectum. Keyhole or laparoscopic surgery, where the surgeon makes a number of small incisions to insert instruments guided by a camera, can avoid the need for open surgery and reduce recovery time.

Robot-assisted surgery, where the surgeon guides a robot to perform laparoscopic surgery, was introduced as a potential solution to some of the technical difficulties of the keyhole approach in the pelvis. However, the evidence is limited. This trial aimed to address that knowledge gap.

What did this study do?

The ROLARR trial compared robotic-assisted surgery with laparoscopic surgery for rectal cancer resection by looking at the number of operations which had to be converted to open surgery. Single centre studies had shown some advantage of robotic over laparoscopic surgery in terms of lower conversion rates, and suggested improved post-operative bladder and sexual function in the robotic-assisted arm.

However, the main disadvantage of robotic, compared with laparoscopic, surgery is the increased hospital costs. The authors, therefore, selected the main outcome as one that measures the ease of operating (the conversion rates) as well as looking at clinical operative outcomes including having clear margins, and later clinical outcomes such as recurrence.

This was a multicentre randomised trial conducted in ten developed countries, including the UK, during 2014 and 2015. A total of 466 patients underwent surgery: 236 via laparoscopic and 230 via robotic-assisted techniques. The average age of participants was 65, and 68% were men. Participants were followed-up for up to three years.

The trial had some limitations. There were 40 surgeons involved, with varying degrees of experience, especially with robotic surgery. Some sub-analyses were limited due to small numbers, such as comparing results for obese and very obese patients.

What did it find?

  • There was no significant difference in the rate of conversion to open surgery, at 28/230 (12.2%) in the laparoscopic group and 19/236 (8.1%) in the robotic group (adjusted odds ratio [aOR] 0.6, 95% confidence interval [CI] 0.3 to 1.2).
  • Positive surgical margins (cancer cells at the edge of the surgically removed tissue) occurred in a similar proportion, at 14/224 (6.3%) of the laparoscopic group compared with 12/235 (5.1%) of the robotic group (aOR 0.8, 95% CI 0.4 to 1.8).
  • There was no significant difference in post-operative complications within 30 days, occurring in 73/230 (31.7%) after laparoscopic surgery compared with 78/236 (33.1%) after robotic surgery (aOR 1.0, 95% CI 0.7 to 1.6). Post-operative complications between 30 days and six months after the operation were also similar, 38/230 (16.5%) after laparoscopic surgery compared with 34/236 (14.4%) after robotic surgery (aOR 0.7, 95% CI 0.4 to 1.3).
  • Other measures, including intra-operative complications, bladder function, sexual function, fatigue, physical and mental general health, three-year recurrence, disease-free survival and overall survival were similar across the groups.
  • The cost of robotic surgery was £980 higher due to the longer duration of surgery and cost of instruments.

What does current guidance say on this issue?

NICE guideline CG131 (2011, updated 2014) recommends that laparoscopic resection is performed as an alternative to open resection for individuals with colorectal (bowel) cancer in whom both laparoscopic and open surgery are considered suitable, but currently does not mention robotic surgery.

This guideline is due to be further updated, and in August 2019 NICE published a draft guideline for consultation. This states that laparoscopic surgery should be offered for rectal cancer, with open surgery being considered where clinically indicated. It says robotic surgery should only be considered within established programmes that have appropriate audited outcomes. The final guideline is due to be published in January 2020.

What are the implications?

Overall, the trial results do not support the extra costs involved in performing surgical resection using robotic-assisted laparoscopy for this indication and in this population group.

Citation and Funding

Jayne D, Pigazzi A, Marshall H et al. Robotic-assisted surgery compared with laparoscopic resection surgery for rectal cancer: the ROLARR RCT. Efficacy and Mechanism Evaluation. 2019;6(10).

This project was funded by the Efficacy and Mechanism Evaluation (EME) programme (project number 08/52/01). Additional funding was provided by the Chief Scientist Office, Scottish Government Health and Social Care Directorate, Health and Care Research Wales and the Health and Social Care Research and Development Division, Public Health Agency in Northern Ireland.

Bibliography

Day A, Tilney H and Gudgeon M. Robotic rectal cancer surgery offers significant benefits over the laparoscopic technique. Gut. 2015;64:A332.

NHS website. Treatment: bowel cancer. London: Department of Health and Social Care; updated 2019.

NICE. Colorectal cancer: diagnosis and management. CG131. London: National Institute for Health and Social Care Excellence; 2014.

NICE. Colorectal cancer, update. Draft for consultation. London: National Institute for Health and Social Care Excellence; 2019.

Office for National Statistics. Cancer registration statistics, England: 2017. London: Office for National Statistics; April 2019.

Office for National Statistics. Cancer survival in England – adults diagnosed 2013 – 2017. London: Office for National Statistics; August 2019.

Why was this study needed?

There were 9,614 cases of rectal cancer in England in 2017. It is more common in older people, with most cases occurring after the age of 60. Data between 2013 and 2017 shows more than 80% survive for at least one year after diagnosis and 60% survive for at least five years.

Surgery is the most common treatment for rectal cancer and a number of techniques may be used. Open surgery requires the surgeon to make a large cut in the abdomen and sometimes the perineum to access the rectum. Keyhole or laparoscopic surgery, where the surgeon makes a number of small incisions to insert instruments guided by a camera, can avoid the need for open surgery and reduce recovery time.

Robot-assisted surgery, where the surgeon guides a robot to perform laparoscopic surgery, was introduced as a potential solution to some of the technical difficulties of the keyhole approach in the pelvis. However, the evidence is limited. This trial aimed to address that knowledge gap.

What did this study do?

The ROLARR trial compared robotic-assisted surgery with laparoscopic surgery for rectal cancer resection by looking at the number of operations which had to be converted to open surgery. Single centre studies had shown some advantage of robotic over laparoscopic surgery in terms of lower conversion rates, and suggested improved post-operative bladder and sexual function in the robotic-assisted arm.

However, the main disadvantage of robotic, compared with laparoscopic, surgery is the increased hospital costs. The authors, therefore, selected the main outcome as one that measures the ease of operating (the conversion rates) as well as looking at clinical operative outcomes including having clear margins, and later clinical outcomes such as recurrence.

This was a multicentre randomised trial conducted in ten developed countries, including the UK, during 2014 and 2015. A total of 466 patients underwent surgery: 236 via laparoscopic and 230 via robotic-assisted techniques. The average age of participants was 65, and 68% were men. Participants were followed-up for up to three years.

The trial had some limitations. There were 40 surgeons involved, with varying degrees of experience, especially with robotic surgery. Some sub-analyses were limited due to small numbers, such as comparing results for obese and very obese patients.

What did it find?

  • There was no significant difference in the rate of conversion to open surgery, at 28/230 (12.2%) in the laparoscopic group and 19/236 (8.1%) in the robotic group (adjusted odds ratio [aOR] 0.6, 95% confidence interval [CI] 0.3 to 1.2).
  • Positive surgical margins (cancer cells at the edge of the surgically removed tissue) occurred in a similar proportion, at 14/224 (6.3%) of the laparoscopic group compared with 12/235 (5.1%) of the robotic group (aOR 0.8, 95% CI 0.4 to 1.8).
  • There was no significant difference in post-operative complications within 30 days, occurring in 73/230 (31.7%) after laparoscopic surgery compared with 78/236 (33.1%) after robotic surgery (aOR 1.0, 95% CI 0.7 to 1.6). Post-operative complications between 30 days and six months after the operation were also similar, 38/230 (16.5%) after laparoscopic surgery compared with 34/236 (14.4%) after robotic surgery (aOR 0.7, 95% CI 0.4 to 1.3).
  • Other measures, including intra-operative complications, bladder function, sexual function, fatigue, physical and mental general health, three-year recurrence, disease-free survival and overall survival were similar across the groups.
  • The cost of robotic surgery was £980 higher due to the longer duration of surgery and cost of instruments.

What does current guidance say on this issue?

NICE guideline CG131 (2011, updated 2014) recommends that laparoscopic resection is performed as an alternative to open resection for individuals with colorectal (bowel) cancer in whom both laparoscopic and open surgery are considered suitable, but currently does not mention robotic surgery.

This guideline is due to be further updated, and in August 2019 NICE published a draft guideline for consultation. This states that laparoscopic surgery should be offered for rectal cancer, with open surgery being considered where clinically indicated. It says robotic surgery should only be considered within established programmes that have appropriate audited outcomes. The final guideline is due to be published in January 2020.

What are the implications?

Overall, the trial results do not support the extra costs involved in performing surgical resection using robotic-assisted laparoscopy for this indication and in this population group.

Citation and Funding

Jayne D, Pigazzi A, Marshall H et al. Robotic-assisted surgery compared with laparoscopic resection surgery for rectal cancer: the ROLARR RCT. Efficacy and Mechanism Evaluation. 2019;6(10).

This project was funded by the Efficacy and Mechanism Evaluation (EME) programme (project number 08/52/01). Additional funding was provided by the Chief Scientist Office, Scottish Government Health and Social Care Directorate, Health and Care Research Wales and the Health and Social Care Research and Development Division, Public Health Agency in Northern Ireland.

Bibliography

Day A, Tilney H and Gudgeon M. Robotic rectal cancer surgery offers significant benefits over the laparoscopic technique. Gut. 2015;64:A332.

NHS website. Treatment: bowel cancer. London: Department of Health and Social Care; updated 2019.

NICE. Colorectal cancer: diagnosis and management. CG131. London: National Institute for Health and Social Care Excellence; 2014.

NICE. Colorectal cancer, update. Draft for consultation. London: National Institute for Health and Social Care Excellence; 2019.

Office for National Statistics. Cancer registration statistics, England: 2017. London: Office for National Statistics; April 2019.

Office for National Statistics. Cancer survival in England – adults diagnosed 2013 – 2017. London: Office for National Statistics; August 2019.

Robotic-assisted surgery compared with laparoscopic resection surgery for rectal cancer: the ROLARR RCT

Published on 26 September 2019

Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Edlin R, Hulme C & Brown J.

 Efficacy and Mechanism Evaluation  Volume 6 Issue 10 , 2019

Background Robotic rectal cancer surgery is gaining popularity, but there are limited data about its safety and efficacy. Objective To undertake an evaluation of robotic compared with laparoscopic rectal cancer surgery to determine its safety, efficacy and cost-effectiveness. Design This was a multicentre, randomised trial comparing robotic with laparoscopic rectal resection in patients with rectal adenocarcinoma. Setting The study was conducted at 26 sites across 10 countries and involved 40 surgeons. Participants The study involved 471 patients with rectal adenocarcinoma. Recruitment took place from 7 January 2011 to 30 September 2014 with final follow-up on 16 June 2015. Interventions Robotic and laparoscopic rectal cancer resections were performed by high anterior resection, low anterior resection or abdominoperineal resection. There were 237 patients randomised to robotic and 234 to laparoscopic surgery. Follow-up was at 30 days, at 6 months and annually until 3 years after surgery. Main outcome measures The primary outcome was conversion to laparotomy. Secondary end points included intra- and postoperative complications, pathological outcomes, quality of life (QoL) [measured using the Short Form questionnaire-36 items version 2 (SF-36v2) and the Multidimensional Fatigue Inventory-20 (MFI-20)], bladder and sexual dysfunction [measured using the International Prostatic Symptom Score (I-PSS), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI)], and oncological outcomes. An economic evaluation considered the costs of robotic and laparoscopic surgery, including primary and secondary care costs up to 6 months post operation. Results Among 471 randomised patients [mean age 64.9 years, standard deviation (SD) 11.0 years; 320 (67.9%) men], 466 (98.9%) patients completed the study. Data were analysed on an intention-to-treat basis. The overall rate of conversion to laparotomy was 10.1% and occurred in 19 (8.1%) patients in the robotic-assisted group and in 28 (12.2%) patients in the conventional laparoscopic group {unadjusted risk difference 4.12% [95% confidence interval (CI) ā€“1.35% to 9.59%], adjusted odds ratio 0.61 [95% CI 0.31 to ā€“1.21]; pā€‰=ā€‰0.16}. Of the nine prespecified secondary end points, including circumferential resection margin positivity, intraoperative complications, postoperative complications, plane of surgery, 30-day mortality and bladder and sexual dysfunction, none showed a statistically significant difference between the groups. No difference between the treatment groups was observed for longer-term outcomes, disease-free and overall survival (OS). Males were at a greater risk of local recurrence than females and had worse OS rates. The costs of robotic and laparoscopic surgery, excluding capital costs, were £11,853 (SD £2940) and £10,874 (SD £2676) respectively. Conclusions There is insufficient evidence to conclude that robotic rectal surgery compared with laparoscopic rectal surgery reduces the risk of conversion to laparotomy. There were no statistically significant differences in resection margin positivity, complication rates or QoL at 6 months between the treatment groups. Robotic rectal cancer surgery was on average £980 more expensive than laparoscopic surgery, even when the acquisition and maintenance costs for the robot were excluded. Future work The lower rate of conversion to laparotomy in males undergoing robotic rectal cancer surgery deserves further investigation. The introduction of new robotic systems into the market may alter the cost-effectiveness of robotic rectal cancer surgery.

Expert commentary

Robotic-assisted (using a robot controlled by the operating surgeon) laparoscopic (keyhole) surgery as compared to conventional laparoscopic surgery (no robot) did not reduce the risk of conversion to laparotomy. Laparotomy was the standard approach before the introduction of laparoscopic surgery among patients undergoing surgery for rectal cancer.

Secondary outcomes, including intra-operative complications, post-operative complications, complete excision of the cancer, quality of life, mortality, and bladder and sexual dysfunction, were not significantly different between the groups.

Robotic laparoscopic surgery takes longer, is more expensive than conventional laparoscopic surgery and does not confer an advantage in rectal cancer surgery. Robotic surgery may be beneficial in the narrower male pelvis.

Seamus Kelly, Consultant Colorectal Surgeon, NHS Northumbria Healthcare, NHS Foundation Trust

The commentator declares no conflicting interests