Robot-assisted surgery used to remove and reconstruct bladder cancer allows patients to recover much faster and spend significantly less time (20%) in hospital, first-of-its-kind clinical trial finds conducted by scientists from UCL and the University of Sheffield.
The study, published in JAMA and funded by the Urology Foundation with a grant from the Champniss Foundation, also found that robotic surgery halved the risk of readmission (52%) and found a “striking” fourfold ( 77%) reduction in the prevalence of blood clots (deep vein thrombus and pulmonary embolism) – a major cause of health decline and morbidity – compared to patients who underwent open surgery.
Patients’ physical activity – assessed by daily steps tracked on a wearable smart sensor – endurance and quality of life also increased.
Unlike open surgery, where a surgeon works directly on a patient and involves large incisions in skin and muscle, robot-assisted surgery allows surgeons to remotely guide minimally invasive instruments using a console and using a 3D view. It is currently only available in a small number of UK hospitals.
The researchers say the results provide the strongest evidence to date for the patient benefits of robot-assisted surgery and are now urging the National Institute for Clinical Excellence (NICE) to make it available as a clinical option. across the UK for all major abdominal surgeries including colorectal, gastrointestinal and gynecological.
Co-lead researcher Professor John Kelly, Professor of Uro-Oncology in the Division of Surgery and Interventional Sciences at UCL and Consultant Surgeon at University College London Hospitals, said: “While the robot-assisted surgery becomes more widely available, there has been no evaluation of its overall benefit to patient recovery.
“In this study, we wanted to establish whether robot-assisted surgery, compared to open surgery, reduced time spent in hospital, reduced readmissions and led to better levels of fitness and quality of life; on all points, this has been demonstrated.
“An unexpected finding was the striking reduction in blood clots in patients undergoing robotic surgery; this indicates safe surgery with patients enjoying far fewer complications, earlier mobilization and a faster return to life. normal.
Co-lead investigator Professor James Catto, Professor of Urological Surgery in the Department of Oncology and Metabolism at the University of Sheffield, said: “This is an important finding. Time spent in the hospital is reduced and recovery is faster when using this advanced surgery.
“Ultimately, this will reduce the pressure of beds on the NHS and get patients home faster. We are seeing fewer complications due to improved mobility and reduced time spent in bed.
“The study also indicates future trends in health care. Soon, we may be able to monitor post-release recovery, to find these issues developing. It’s possible that tracking gait levels will highlight those who need a district nurse visit or perhaps an earlier check-up at the hospital.
“Previous robotic surgery trials have focused on longer-term results. They showed similar cancer cure rates and similar levels of long-term recovery after surgery. None examined differences in the immediate days and weeks after surgery.
Open surgery remains NICE’s “gold standard” recommendation for very complex surgeries, although the research team hopes that may change.
Professor Kelly added: “In light of the positive results, the perception of open surgery as the gold standard for major surgeries is now being challenged for the first time.
“We hope that all eligible patients requiring major abdominal operations can now be offered the option of undergoing robotic surgery.”
Rebecca Porta, CEO of the Urology Foundation, said, “The mission of the Urology Foundation is simple: to save lives and reduce suffering caused by cancers and urological diseases. We do this by investing in cutting-edge research, leading education and supporting the training of healthcare professionals to ensure fewer lives are devastated.
“We are proud to have been at the heart of the step change in the treatment and care of patients in urology since our inception 27 years ago, and the results of this trial will improve the treatment and care of patients with a bladder cancer.
Bladder cancer is where a growth of abnormal tissue, called a tumor, develops in the lining of the bladder. In some cases, the tumor spreads into the muscle of the bladder and can lead to secondary cancer in other parts of the body. Around 10,000 people are diagnosed with bladder cancer in the UK every year and over 3,000 bladder removals and reconstructions are performed. It is one of the most expensive cancers to manage.
Across nine UK hospitals, 338 patients with non-metastatic bladder cancer were randomized into two groups: 169 patients underwent robot-assisted radical cystectomy (removal of the bladder) with intracorporeal reconstruction (the process of removing a section intestine to make a new bladder) and 169 patients underwent open radical cystectomy.
The primary endpoint of the trial was the length of hospital stay after surgery. On average, the robot-assisted group stayed eight days in the hospital, compared to 10 days for the open surgery group, a reduction of 20%. Hospital readmission within 90 days of surgery was also significantly reduced – 21% for the robot-assisted group versus 32% for the open group.
Twenty other secondary outcomes were assessed at 90 days, six and 12 months after surgery. These included blood clot prevalence, wound complications, quality of life, disability, endurance, activity levels and survival (morbidity). All secondary outcomes were improved by robot-assisted surgery or, if not improved, nearly equal to open surgery.
This study, and previous studies, show that robot-assisted surgery and open surgery are equally effective when it comes to cancer recurrence and survival time.
The research team is conducting a health economic analysis to establish the quality-adjusted life year (QALY), which incorporates the impact on the quantity and quality of life.
Patient Case Studies
John Hammond, pensioner, 75, from Doncaster, said: ‘I left my symptoms too long and found out I had a tumor in my bladder. I had the chance to see Professor Catto and after having options I chose the operation to remove my bladder and put a stoma in place.
“I had the operation in August 2019 and was aware it was robotic surgery as part of a trial and was eager to take part; in fact, I was happy to be able to help someone else in the future with this type of surgery. The operation was a success and the whole team was very supportive.
“Amazingly, I was walking the next day and made great progress, improving my walking every day. I had no pain and just had to adjust to the ostomy bag. I fully recovered from the operation and always knew I was in professional hands. I was home about five days after the operation and I am grateful to Professor Catto and his team that I was not hospitalized longer than necessary.
Frances Christensen Essendon, from Hertfordshire, said: ‘I was diagnosed with bladder cancer and after chemotherapy I was suggested to have my bladder removed. Under the guidance of Professor John Kelly, I underwent robotic surgery to remove my native bladder which was replaced with a new bladder made from intestine. The operation was a success and I was up and walking shortly after the operation. Having had surgery in April, I returned to work and the gym in mid-June. I continued to lead a normal active life and am forever grateful to Professor Kelly and his team for their care and support.
The trial ran from March 2017 to March 2020 and involved 29 surgeons across nine UK hospital trusts, namely; University College London Hospitals NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Guys and St Thomas’ NHS Foundation Trust, NHS Greater Glasgow and Clyde, Royal Berkshire NHS Foundation Trust, St James University Hospital Leeds, Royal Liverpool and Broadgreen University Hospitals NHS Trust , Royal Devon and Exeter NHS Trust and North Bristol NHS Trust.
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