21 April 2020
The following article was originally published by Gilbert Wong as part of The Challenge series, highlighting researchers at The University of Auckland who are tackling big-world problems. It is republished here with permission.
A clever device invented here is reducing the recovery time for people who have had surgery for bowel cancer. This saves millions of dollars but more importantly patients are in much better shape to resume their lives.
Greg O’Grady, associate professor in surgery at the University of Auckland.
The University of Auckland is ranked No.1 globally in the Times Higher Education University Impact Rankings for 2020 (also no.1 in 2019). The rankings assess how universities are working towards the UN Sustainable Development Goals. It surprises people to learn that bowel cancer is the most commonly reported cancer in New Zealand. Each year bowel cancer claims the lives of more than 1200 people, four times our road toll.
After lung cancer, it’s the second highest cause of cancer death in the country. New Zealand has the fifth highest death rate from bowel cancer in the world and it remains a health measure where we lag behind our OECD comparators.
If that is the big picture, then Greg O’Grady sees the up close and personal detail every day in his work as a general surgeon specialising in colorectal surgery at Auckland City Hospital. Greg is also an Associate Professor in Surgery at the School of Medicine at the University of Auckland, where he leads the Surgical Engineering Lab at the Auckland Bioengineering Institute.
“There’s been dramatic advances in surgical techniques and how we diagnose bowel cancer but recovery from surgery is still a problem. Patients often suffer setbacks and loss of quality of life,” he says.
He and his team were awarded a prestigious $5m grant from the Health Research Council to look at how to enhance the recovery and rehabilitation of patients who have had bowel cancer surgery. A key issue is the time it takes for normal gut function to return following surgery.
“Often for several days, patients can’t eat, they feel nauseous and they need to vomit. If they can take some food, they feel bloated. And they can’t pass any bowel motions or wind. We obviously can’t help patients return home when they are like this.”
The goal is faster recovery of bowel function.
And the longer these patients spend in hospital, the more likely they are to experience further complications like infection. The mere fact of being confined to bed for days makes it harder to resume normal life.
The wait for gut function to return is down to a poorly understood problem known as an ‘Ileus’ and it affects a quarter of bowel surgery patients. The team are currently finishing a major randomised trial of a new drug that could help to prevent ileus, allowing patients to recover faster. If the results are positive, the results could potentially help to reduce the costs of bowel cancer care for the NZ health system by up to $1m per year.
Bowel cancer surgery also commonly creates another major challenge for patients called a “temporary Ileostomy”, where the diseased part of the bowel is removed and the cut end diverted to an artificial opening in the stomach wall, known as a stoma to which a bag is attached, a short term bypass to allow time for the bowel to heal and normal gut function to resume.
Some of the sickest patients Greg sees in Auckland are those who have an “enterocutaneous fistula”, which for bowel surgery patients is essentially a leak from the bowels to the skin. “This happens from complications from surgery and serious wounds. These patients are often terribly unwell and some need to stay in hospital up to six months to recover. A fistula is a bit like having a stoma, but often comes with a very high output of bowel contents each day, and needs highly specialised care.”
The stoma bag is a necessary intervention, but it commonly brings complications of its own. Patients risk dehydration, which in turn can lead to kidney damage. It also slows down the natural recovery process because it prevents the normal digestive process through the different sections of the bowel. “We’re talking about what is not yet a “waste product”, but rather a mix of water and nutrients that are important for hydration, the microbiome and for the nutrition of the bowel.”
The team at the Surgical Engineering Lab
The complications cause misery for the patients and require ingenuity, expertise and care from the medical team. This is what happens now in a first world hospital system. A close colleague of Greg’s, fellow surgeon Ian Bisset, also of the University of Auckland saw first-hand how much more distressing these issues are in the developing world health system of Nepal, where he worked for many years as one of the country’s small band of surgeons.
One patient in particular, always troubled him. A 29-year-old mother with an infection that had left her digestion system broken. Ian did his best, but her wounds leaked digestive fluids into her blood. Her gut function failed to return to normal and she died from lack of nutrition. Ian became friends with her then 12-year-old son, who was his mother’s main caregiver, visiting her each day to bring food and wash her.
The impetus for a solution to this common problem came in large part from Ian’s wish for a simple, safe way to treat such patients, no matter where in the world they might be. A team, based at the Auckland Bioengineering Institute and clinically-led by Greg and Ian, have invented a clever pump design that sits inside a patient’s stoma bag. Magnets secure it and allow it to be operated without interfering with the inside of the bag. As the stoma bag fills, instead of it being emptied, the pump is brought into action and it drives the content, known as chyme, the semi-fluid mix of nutrients, water and electrolytes, back into the colon.
The reason this is a breakthrough is that once a patient is fitted with a stoma bag, they usually have it with them for an average of four and a half months, even if their bowel surgery has healed and there is no risk of leaks. This timeframe can be even longer if patients are on chemotherapy, or have a fistula. The long period is due to internal scarring which makes it unsafe to operate to reverse the stoma or fix a fistula for many months, and because patients on chemotherapy are at risk of infections, which also prevents surgery.
“We found a range of benefits, from improved nutrition to patients being able to return to eating again sooner.”
Associate Professor Greg O’Grady
University of Auckland
“So the patient is stuck with a stoma bag for months, sometimes up to nine months. But technically many of them only need the bag for a week or so, until the bowel has healed. From that point on, they are only getting the downsides of the stoma, the loss of fluid, nutrition and beneficial gut bacteria.
By restoring how the chyme naturally passes through the bowel, patients in clinical trials at Auckland City Hospital have been able to go home 40 percent faster, cutting their time in hospital almost in half and speeding the return of normal gut function.
Greg says, “We found a range of benefits, from improved nutrition to patients being able to return to eating again sooner. In fistula patients, nutrition and liver function was better because patients were getting the right mix and amount of electrolytes and important salts were recirculating normally again.”
The patients felt better, says Greg. “They really like it. They can feel normal again, and they have confidence that their bowels are going to eventually function normally again, as a lot of patients are very nervous about that aspect.”
With support from UniServices, the University’s commercialisation arm, and funding from the MedTech Centre for Research Excellence, hosted by the University, the intellectual property has been spun out into the Insides Company, and raised $4.3m from angel investors. International interest has been high. The device now known commercially as The Insides™ Systemfi. Clinical studies in bowel cancer patients were also being supported with a generous grant from the New Zealand Cancer Society.
The device has met the standard from medical devices in the European Union and is already in use in Germany and the United Kingdom. In June 2019, the American FDA granted the device breakthrough status, a first for a device from New Zealand, and aimed at ensuring more timely access to the device in the United States. Greg and The Insides Company have other ideas for making life better for bowel cancer patients, including eventually doing away with stoma bags altogether.
Worldwide the stoma device sector is a $5bn a year market. The device creates an entirely new category, chyme recycling, which in turn enables faster recuperation and the removal of the stoma bag far sooner.
For Greg, it has been a heady ride. “We’re wanting to save money for the health system, make life easier for our patients and help grow the medical device industry in New Zealand. It’s that alignment that really drives me.”