Wearable tech, AI and clinical teams combine to change the face of clinical trial monitoring
23 January 2023
Publish date: 16 May 2022
Robot-assisted surgery used to perform bladder cancer removal and reconstruction enables patients to recover far more quickly and spend significantly (20%) less time in hospital, concludes a first-of-its kind clinical trial led by UCLH, UCL and the University of Sheffield, and funded by The Urology Foundation and the Champniss Foundation.
The study, published in the Journal of the American Medical Association, also found robotic surgery reduced the chance of readmission by half (52%), and revealed a “striking” four-fold (77%) reduction in prevalence of blood clots (deep vein thrombus & pulmonary emboli) – a significant cause of health decline and morbidity – when compared to patients who had open surgery.
Patients’ physical activity – assessed by daily steps tracked on a wearable smart sensor – and their stamina and quality of life also increased.
Researchers say the findings provide the strongest evidence so far of the patient benefit of robot-assisted surgery and are now urging the National Institute of Clinical Excellence (NICE) to make it available as a clinical option across the UK for all major abdominal surgery including colorectal, gastro-intestinal, and gynaecological.
Co-Chief Investigator, Professor John Kelly, consultant surgeon at UCLH and Professor of Uro-Oncology at UCL, said: “Despite robot-assisted surgery becoming more widely available, there has been no significant clinical evaluation of its overall benefit to patients’ recovery.
“In this study we wanted to establish if robot-assisted surgery, when compared to open surgery reduced time spent in hospital, reduced readmissions, and led to better levels of fitness and a quality of life; on all counts this was shown.
“An unexpected finding was the striking reduction in blood clots in patients receiving robotic surgery; this indicates a safe surgery with patients benefiting from far less complications, early mobilisation and a quicker return to normal life.”
Unlike open surgery, where a surgeon works directly on a patient and involves large incisions in the skin and muscle, robot-assisted surgery allows surgeons to guide minimally invasive instruments remotely using a console and aided by 3D view. It is currently only available in a small number of UK hospitals.
Open surgery remains the NICE “gold standard” recommendation for highly complex surgery, though the research team hope this could 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 challenged for the first time. We hope that all eligible patients needing major abdominal operations can now be offered the option of having robotic surgery.”
Bladder cancer is where a growth of abnormal tissue, known as a tumour, develops in the bladder lining. In some cases, the tumour spreads into the bladder muscle and can lead to secondary cancer in other parts of the body. About 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 randomised into two groups: 169 patients had robot-assisted radical cystectomy (bladder removal) with intracorporeal reconstruction (process of taking section of bowel to make new bladder), and 169 patients open radical cystectomy.
The trial’s primary end-point was length of stay in hospital post-surgery. On average, the robot-assisted group stayed eight days in hospital, this compared to 10 days for the open surgery group – so a 20% reduction. Readmittance to hospital within 90 days of surgery was also significantly reduced – 21% for the robot-assisted group vs 32% for open.
A further 20 secondary outcomes were assessed at 90 days, six- and 12-months post-surgery. These included blood clot prevalence, wound complications, quality of life, disability, stamina, activity levels, and survival (morbidity). All secondary outcomes were improved by robot-assisted surgery or, if not improved, almost equal to open surgery.
This study, and previous studies, show both robot-assisted and open surgery are equally as effective in regards cancer recurrence and length of survival.
The research team is conducting a health economic analysis to establish the quality-adjusted life year (QALY), which incorporates the impact on both the quantity and quality of life.
Frances Christensen Essendon, from Hertfordshire, said: “I was diagnosed with bladder cancer and after a course of chemotherapy it was suggested that I have my bladder removed. Under professor John Kelly I underwent robotic surgery to remove my native bladder which was replaced with a new bladder made out of bowel. The operation was a success, and I was up and walking soon after surgery. Having had the operation in April I was back to work and the gym in the middle of June. I have gone on to lead a normal active life and am eternally grateful to Prof Kelly and his team for their care and support.”
Image: Frances Christensen
23 January 2023
10 January 2023