Robot-assisted surgery for bladder cancer removal and reconstruction allows patients to recover much faster and spend significantly (20 percent) less time in hospital, concludes a first clinical study of its kind led by scientists at 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 reduced the likelihood of readmission in half (52 percent), revealing a “striking” fourfold (77 percent) ) 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 have had open surgery.
Patients’ physical activity — assessed by daily steps tracked on a wearable smart sensor — also increased endurance and quality of life.
Unlike open surgery, where a surgeon works directly on a patient, making large incisions in the skin and muscles, robotic-assisted surgery allows surgeons to guide minimally invasive instruments remotely using a console and aided by 3D rendering. It is currently only available in a small number of UK hospitals.
Researchers say the findings provide the strongest evidence to date of the patient benefit of robotic-assisted surgery and are now urging the National Institute of Clinical Excellence (NICE) to make it available as a clinical option in the UK for all major abdominal surgeries, including colorectal, gastrointestinal, and gynecological.
Co-principal investigator, Professor John Kelly, professor of uro-oncology in UCL’s Division of Surgery & Interventional Science and consultant surgeon at University College London Hospitals, said: “Despite robotic-assisted surgery becoming more widely available, there is no significant clinical evaluation. of the overall benefit to the patient’s recovery.
“In this study, we wanted to determine whether robot-assisted surgery, compared to open surgery, reduced hospital time, reduced readmissions and improved fitness and quality of life; this was demonstrated on all counts.
“An unexpected finding was the marked reduction in blood clots in patients undergoing robotic surgery; this indicates a safe operation with patients benefiting from far fewer complications, early mobilization and a faster return to normal life.”
Co-lead researcher 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 in hospital is reduced and recovery is faster when using this advanced surgery.
“Ultimately, this will reduce bed pressure on the NHS and allow patients to return home faster. We see fewer complications due to the improved mobility and less time in bed.
“The research also points to future trends in healthcare. Soon we may be able to monitor the post-discharge recovery to find those who develop problems. It is possible that tracking gait levels would flag people who need a visit from a district nurse or perhaps an earlier check-up in the hospital.”
“Previous trials of robotic surgery focused on longer-term outcomes. They have shown similar cancer cure rates and comparable long-term recovery rates after surgery. No one looked at differences in the immediate days and weeks after surgery.”
Open surgery remains the NICE’s “gold standard” recommendation for highly complex surgeries, though the research team hopes this may change.
Professor Kelly added: “In light of the positive findings, the perception of open surgery as the gold standard for major surgery is now being put to the test for the first time.
“We hope that all eligible patients requiring major abdominal surgery can now be given the opportunity to undergo robotic surgery.”
Rebecca Porta, CEO of The Urology Foundation said: “The mission of the Urology Foundation is simple: to save lives and reduce the suffering caused by urological cancers and diseases. We do this by investing in cutting-edge research, leading education and supporting the training of health professionals to ensure fewer lives are destroyed.
“We are proud to have been at the center of incremental change in the treatment and care of urology patients since our inception 27 years ago, and the results of this trial will improve the treatment and care of bladder cancer patients.”
In bladder cancer, a growth of abnormal tissue, known as a tumor, develops in the lining of the bladder. In some cases, the tumor spreads to the bladder muscle and can lead to secondary cancer in other parts of the body. Every year in the UK about 10,000 people are diagnosed with bladder cancer and more than 3,000 bladder removals and reconstructions are performed. It is one of the most expensive cancers to treat.
In nine UK hospitals, 338 patients with non-metastatic bladder cancer were randomized into two groups: 169 patients had robotic-assisted radical cystectomy (removal of the bladder) with intracorporeal reconstruction (process of taking part of the bowel to create a new bladder ), and 169 patients had open radical cystectomy.
The primary endpoint of the study was length of hospital stay after surgery. The robot-assisted group spent an average of eight days in the hospital, compared to 10 days for the open surgery group, a 20% reduction. Readmission to hospital within 90 days of surgery was also significantly reduced – 21% for the robot-assisted group versus 32% for open.
An additional 20 secondary outcomes were assessed at 90 days, six and 12 months postoperatively. These include the prevalence of blood clots, wound complications, quality of life, disability, endurance, activity levels, and survival (morbidity). All secondary outcomes were improved by robotic-assisted surgery or, if not improved, nearly equal to open surgery.
This study, and previous studies, show that both robotic-assisted and open surgery are equally effective in terms of cancer recurrence and survival.
The research team conducts a health economic analysis to determine the Quality-Adjusted Year of Life (QALY), which takes into account the impact on both quantity and quality of life.
Case Studies from Patients
John Hammond, retired, aged 75, from Doncaster, said: “I persisted with my symptoms for too long and discovered I had a tumor in the bladder. I was lucky enough to see Professor Catto and after being given options I chose before surgery to have my bladder removed and a stoma placed.
“I had the surgery in August 2019 and was aware that it was robotic surgery on a trial and was eager to participate; in fact I was happy to be able to help someone else with this kind of surgery in the future. The operation was successful and the whole team was extremely helpful.
“Amazingly, I was walking the next day and making excellent progress, getting better every day. I had no pain and just had to get used to the ostomy bag. I have fully recovered from the surgery and all the time I knew I was I was home about five days after surgery and am grateful to Professor Catto and his team that I did not have to stay in the hospital longer than I needed to.”
Frances Christensen Essendon, from Hertfordshire, said: “I was diagnosed with bladder cancer and after a course of chemotherapy I was advised to have my bladder removed. Under the guidance of Professor John Kelly, I underwent robotic surgery to remove my original bladder, which was replaced with a new bladder made of gut. The operation was a success and I was able to walk again soon after the operation. After the surgery in April, I was back to work and back to the gym in mid-June. I have come to live a normal active life and am eternally grateful to Prof Kelly and his team for their care and support.”
The trial took place from March 2017 to March 2020 and involved 29 surgeons from 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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