fbpx

PRESS ROOM

To Be Or Ostomy- a thought piece

Dr. Robert Fearn M.D. – 04/26/2022

Intro

As medical professionals we know an ostomy can be a life-saving procedure and can transform the outcomes of someone living with chronic gastrointestinal disease. As a gastroenterologist managing patients with inflammatory bowel disease, colorectal cancer and intestinal failure, ostomy has always been part of my armory for dealing with these conditions. But do we really understand what a patient goes through when they become an ’ostomate’? The changes in anatomy, physiology and self-image are so profound that it is unsurprising complication rates are so high.

So first the surgery itself. An intestinal (or diversionary) stoma is created for one of three reasons. It may not be physically possible to join the cut ends of bowel together; joining the ends together would create symptoms too intrusive to justify; or a join in the bowel is at a very high risk of leakage and needs to be protected from the flow of feces. This means that those having the operation have often come to the end of a long journey of treatments and escalations where ostomy has been the thing to avoid at all costs. The fact that this is being considered as ‘better than the alternative’ is of little reassurance when it feels to the patient like a choice between the devil and the deep blue sea.

Following surgery, 2 in 5 new ostomy patients will return to hospital as an emergency at least once1. The majority of these are for dehydration related complications or skin and wound issues- a shorter gut with less surface to absorb fluids and electrolytes leading to volume losses and leaks of feces into their wound. The problems don’t go away after surgery either. A quarter of stoma patients will have developed renal failure within 2 years2 and nearly 80% have ongoing issues with leakage and skin irritation3.

11 Health was conceived and founded by a patient which has framed how we go about everything we do. When we were thinking about how to design solutions for new ostomy patients, one of the things that was very important was supporting patients through this early transition in an intuitive and data driven way. Today our team consists of patients, clinicians, engineers and developers who are obsessed with solving real problems faced by this unique group of patients.

Michael Seres - Founder of 11 Health and Technologies

The Solution

Our belief is that if we provide stoma patients with the tools to understand their condition, to identify risk factors as they emerge and give them the tools to manage these risks themselves, or with their clinical teams, at an early stage then we can prevent the longer-term complications from ever occurring. We also believe that for a tool like this to be effective, it must be simple, ‘delightful’ and be able to become part of a user’s daily routine without adding extra steps or burden. This is the philosophy behind Connected Care, where connected ostomy wearables can provide continuous, passively collected real-time data from the patient and provide them actionable insights in an accessible format.

In order to track stoma function we have designed a remote output monitor that is embedded into the pouch of a 2-piece drainable stoma appliance. Every part of it has been thought about and designed from the ground up by our team in California. Our research tells us people living with an ostomy do not want medical ‘skin tone’ colors and they value a product that is discrete, quiet and stands up to their daily activities whether that is swimming, exercising, or spending hours sitting at a desk. The discreet and flexible technology we are developing will measure the activity of the stoma and drainage patterns, allowing the output volumes to be calculated and losses tracked over time whilst withstanding the daily activities of an ostomate. We will use these trends and volumes to predict the risk of a patient developing problems like dehydration or early obstruction and offer them information about these risks before a bigger problem develops.

Likewise, our peristomal skin monitor is being designed to seamlessly integrate into the skin barrier or wafer of our connected appliance. Access to patients, physicians and stoma nurses means that only the highest performing materials have been selected for this product and this has impacted everything from the formulation of the hydrocolloid to the size of the wafer itself and introduction of convexity for those with more challenging anatomy. The technology is designed for the purpose of continuously measuring skin surface temperature and moisture levels in order to track for leaks and the signs of inflammation or infection.

Connect Wearable System

Improving outcomes: dehydration

How is this going to change outcomes? Let’s take the example of dehydration in stoma patients. We’ve all felt dehydrated from time-to-time and we normally respond to our thirst by drinking more. But what about if drinking could make the problem worse? The top half of our bowel (the stomach and upper small bowel) produces a lot more liquid than it can absorb- several liters in fact4. We rely on the lower part of our bowel to absorb that excess fluid. Without the colon to absorb fluids and salts from the bowel, drinking more water can actually lead to even more fluid and salts being lost, setting up a vicious cycle that is hard to break. This is most common when a stoma is new, was created high up in the small bowel or the underlying condition (e.g. Crohn’s) is still active4,5.

The more fluid you lose, the harder your body has to work to hold on to what you still have. This means concentrating your urine (making it yellow and strong smelling), lowering your blood pressure (feeling dizzy on standing) and prioritizing blood flow to your vital organs such as your heart and brain. As a result, the kidneys may suffer reduced flow and can be damaged as a result. In some studies, as many as 20% of new ileostomy patients experience this6. Even a single episode of kidney injury has been shown to increase the long-term risk of heart disease, stroke and death7,8.

So, we’re developing algorithms that use your stoma function and bag filling as a way of measuring stoma output and that helps us identify people at risk. A stoma output less than 1000ml per day is generally considered ‘normal’ 9,10 and those with an output level at this volume or higher frequently run into trouble unless they are taking preventative measures. These measures may include drinking electrolyte-containing fluids11, medicines to slow the bowel5 or diagnosing and treating the underlying problem causing output to be high. Occasionally individuals need IV fluids either as a one off or regularly to replace the fluids being lost4.

We’ve designed the app to show a user when the trend in output is increasing over time periods as short as 4 hours and over multiple days. When a threshold is crossed (e.g. 1500ml in 24h) a notification will alert the user to that change. But how will this change the outcome? All our notifications will be linked to health checks and a library of evidence-based information about the risk and steps that are known to reduce those risks. Take high output- a user can measure their heart rate and report any high-risk symptoms before being directed to the learning section to see the most relevant information for their unique situation. Going forward they can monitor fluid intake more closely, even recording the type of fluids consumed to keep up with those ongoing losses.

This doesn’t replace a provider care plan but gives the user a good reason to engage in their existing plan or explain why those recommendations were made in the first place. We believe a more informed patient is a more engaged patient who is likely to enjoy better outcomes. This doesn’t patronize the patient with strict instructions provided without context, but it also doesn’t overwhelm with the volumes of information we as clinicians try to put across in ever shortened encounters.

Simple Navigation

Low output

The exact same principles apply when we see output dropping over short periods such as 4 hours or if it has been below expected levels over 1 or more 24-hour periods. This may indicate impending obstruction and if accompanied by symptoms such as bloating, pain, nausea or vomiting may indicate an impending issue. Rather than wait until the user is symptomatic which has dangers of full obstruction and perforation we would rather indicate at an earlier stage and engage the user in what symptoms to look out for and when to seek help from their team.

Montoring Low Output

Leak and Skin

What about the skin? We know, even years after surgery, up to 80% of stoma patients continue to experience leaks and skin inflammation issues3. Ostomy effluent contains digestive enzymes and strong chemicals that can damage the skin even after short periods12,13 (anyone who has looked after young children knows you don’t want to leave feces against skin for very long). However, skin can also be damaged by changing appliances too often14. So how can we equip patients with the information they need to know when a change is required?

We have developed an array of sensors that surround the stoma in 360o and will measure even very small changes in temperature or moisture. We’re currently refining algorithms that will alert a user if a potential leak has been developed and where that is located. The intent is to provide the alert when the leak is contained by the hydrocolloid but provide ample warning to prevent progression to an uncontained leak or skin inflammation.

Small changes in skin temperature can mean evolving inflammation/ infection of the skin or even a more generalized infection15. We are currently developing algorithms that track these changes in temperature at a very localized level around the stoma and indicate when unexplained changes are occurring. By linking alerts to dedicated health checks, a user can score their symptoms and take an image of the affected area providing them and their team with in-depth information to make decisions about changes in management. Once again, the user is supported by our evidence-based library so, even if they can’t get to their team, they can see what is known to help in these situations.

Leak and Skin

Checking in- what really matters

Sometimes the monitoring data alone does not tell the full story. This is why we have designed a series of health checks even if the user does not have an alert. Heart rate, dehydration symptoms, fluid intake and skin status can all be captured through easy-to-use tools along with a self-rating of what is most relevant to the patient. Years of research tells us that stoma patient report approximately 20% lower quality of life scores than the general population16,17 and this tool allows a user to indicate the areas of greatest need.

This information feeds into progress reports issued to the patient every week in a format that allows them to see how various aspects of their stoma-related health are changing over time. These reports can be used for self-management or shared with healthcare providers to support shared decision making and treatment decisions.

Checking In

Conclusion

Most new ostomates will eventually adjust to their condition- I know that I will see patients weeks or months after their surgery in my clinic and they often consider it one of the best decisions they have made. That often hides the storm of complications and issues that affected them immediately after their procedure which they may have accepted as ‘par for the course’ and some problems (like renal failure) may remain hidden until it’s too late.

We know that decades of ostomy appliance development has not addressed these fundamental unmet needs and we think that stoma patients deserve more. The aim of Connected Care is to support patients through prevention and early intervention wherever those risks present themselves.


References

1. Tyler JA, Fox JP, Dharmarajan S, et al. Acute health care resource utilization for ileostomy patients is higher than expected. Dis Colon Rectum. Dec 2014;57(12):1412-20. doi:10.1097/DCR.0000000000000246
2. L L, KS L, V R, et al. Ileostomy creation in colorectal cancer surgery: risk of acute kidney injury and chronic kidney disease. The Journal of surgical research. 2017 Apr 2017;210doi:10.1016/j.jss.2016.11.039
3. Ratliff CR. Early Peristomal Skin Complications Reported by WOC Nurses. J Wound Ostomy Continence Nurs. 2010 Sep-Oct 2010;37(5):505-10. doi:10.1097/WON.0b013e3181edac57
4. Rowe KM, Schiller LR. Ileostomy diarrhea: Pathophysiology and management. Proc (Bayl Univ Med Cent). Apr 2020;33(2):218-226. doi:10.1080/08998280.2020.1712926
5. Mountford CG, Manas DM, Thompson NP. A practical approach to the management of high-output stoma. Frontline Gastroenterol. Jul 2014;5(3):203-207. doi:10.1136/flgastro-2013-100375
6. Loria A, Melucci A, Speranza J, et al. Acute kidney injury is a common and significant complication following ileostomy formation. Colorectal Dis. 01 2022;24(1):102-110. doi:10.1111/codi.15917
7. Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. Nov 2005;16(11):3365-70. doi:10.1681/ASN.2004090740
8. Lewington AJ, Cerdá J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. Sep 2013;84(3):457-67. doi:10.1038/ki.2013.153
9. Weise WJ, Serrano FA, Fought J, Gennari FJ. Acute electrolyte and acid-base disorders in patients with ileostomies: a case series. Am J Kidney Dis. Sep 2008;52(3):494-500. doi:10.1053/j.ajkd.2008.04.015
10. Kwiatt M, Kawata M. Avoidance and management of stomal complications. Clin Colon Rectal Surg. Jun 2013;26(2):112-21. doi:10.1055/s-0033-1348050
11. Migdanis A, Koukoulis G, Mamaloudis I, et al. Administration of an Oral Hydration Solution Prevents Electrolyte and Fluid Disturbances and Reduces Readmissions in Patients With a Diverting Ileostomy After Colorectal Surgery: A Prospective, Randomized, Controlled Trial. Dis Colon Rectum. Jul 2018;61(7):840-846. doi:10.1097/DCR.0000000000001082
12. M G, JM B, MM B, et al. Moisture-associated skin damage: overview and pathophysiology. Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society. May-Jun 2011 2011;38(3)doi:10.1097/WON.0b013e318215f798
13. Nagano M, Ogata Y, Ikeda M, Tsukada K, Tokunaga K, Iida S. Peristomal Moisture-Associated Skin Damage and Independence in Pouching System Changes in Persons With New Fecal Ostomies. J Wound Ostomy Continence Nurs. 2019 Mar/Apr 2019;46(2):137-142. doi:10.1097/WON.0000000000000491
14. LeBlanc K, Whiteley I, McNichol L, Salvadalena G, Gray M. Peristomal Medical Adhesive-Related Skin Injury: Results of an International Consensus Meeting. J Wound Ostomy Continence Nurs. 2019 Mar/Apr 2019;46(2):125-136. doi:10.1097/WON.0000000000000513
15. Montalto M, Davies F, Marijanovic N, Meads A. Skin surface temperature: a possible new outcome measure for skin and soft tissue infection. Aust Fam Physician. Sep 2013;42(9):653-7.
16. Nichols TR, Inglese GW. The Burden of Peristomal Skin Complications on an Ostomy Population as Assessed by Health Utility and the Physical Component Summary of the SF-36v2. Value Health. 01 2018;21(1):89-94. doi:10.1016/j.jval.2017.07.004
17. Alenezi A, McGrath I, Kimpton A, Livesay K. Quality of life among ostomy patients: A narrative literature review. J Clin Nurs. May 12 2021;doi:10.1111/jocn.15840

December 31st, 2021

Announcement

11 Health & Technologies Receives Funding from Crohn’s & Colitis Foundation IBD Ventures to Further Develop World’s First Digital Ostomy Wearable, The Remote Output Monitor.

Orange County, CA – 11 Health & Technologies Inc., a medical technology company with a proven technology to reduce complications in ostomy patients, announced today that it has received funding from the Crohn’s & Colitis Foundation’s IBD Ventures program to further develop 11 Health’s digitally connected Remote Output Monitor (ROM) to automatically track and monitor stoma patients’ output levels and provide alerts to patients of impending complications.

The ROM gathers stoma data for the patient and their medical team.

The ROM connects wirelessly to the 11 Health App. In the app, patients can review their personal data including risk of dehydration. In turn, the patient’s medical team is able to view the patient’s data through the 11 Health Clinical Dashboard – a HIPAA compliant, remote patient monitoring platform.

Patients with Inflammatory Bowel Disease (IBD) who undergo surgeries to create stoma are continuously at high risk of adverse events that may result in hospitalizations or emergency room visits. Ileostomies are associated with the second highest all-surgery 30-day readmission rates. 11 Health develops novel technologies that can be integrated into ostomy solutions to detect dehydration and reduce the prevalence, severity, and cost of complications in patients with Ileostomies.

The company has shown reductions of up to 80% in 30-day readmissions and 66% in 30-day Emergency Room visits.

Funding from IBD Ventures will support further development of the ROM. The next generation ROM will improve the overall accuracy of daily volume output to help predict and reduce dehydration related complications, achieve lower manufacturing costs to enable broader access to this unique technology solution, and produce even greater comfort and flexibility.

IBD Ventures was developed by the Crohn’s & Colitis Foundation to accelerate research and development of products that aim to improve the quality of life for patients with IBD. During 2021, less than 4% of applicants received funding, demonstrating the selectivity of the program.

“We are thrilled to receive this support from Crohn’s and Colitis Foundation’s IBD Ventures, demonstrating the Foundation’s support for the use of new technologies to improve patient outcomes.” said Bernhard Gilbey, CEO of 11 Health and Technologies. “It is vital for those Crohn’s and Colitis patients who live with a stoma to have access to the kind of technology that makes such a huge difference to their quality of life and which has such a marked effect on reducing the unnecessarily high complications that result from the current technology-free solutions.”

“As the first digital health investment of IBD Ventures, 11 Health’s technology is a cost-effective and patient-friendly approach to reducing post-operative complications – a major cause of morbidity and mortality among IBD patients,” said Gerard Honig, Director of Research Innovation for the Crohn’s & Colitis Foundation. “The Foundation is committed to accelerating the discovery and development of novel research-based solutions, selectively investing in products that can address an unmet need of IBD patients. We look forward to seeing the next generation ROM significantly improve both patient care management and overall patient outcomes in the near future.”


About the Crohn’s & Colitis Foundation

The Crohn’s & Colitis Foundation is a non-profit, volunteer-fueled organization dedicated to finding the cures for Crohn’s disease and ulcerative colitis, and to improving the quality of life of children and adults affected by these diseases. It was founded in 1967 by Irwin M. and Suzanne Rosenthal, William D. and Shelby Modell, and Henry D. Janowitz, M.D.

October 5th, 2021

Announcement

11 Health and Technologies is excited to announce two new appointments to its board of directors.

Garrett Vygantas is a managing director at OSF Innovation, the venture arm of the OSF Health System Consortium and a board member at Inflammatix and Gauss Medical as well as an investor and adviser to numerous other healthcare technology companies.

Phil Christianson is CEO at Health Smart and has more than 30 years of experience leading divisions of Fortune 100 Companies and improving mid-sized companies providing healthplan administration services, disease management, SaaS and health information technology to health plan providers, health plans and employers.

Bernhard Gilbey, CEO at 11 Health and Technologies, commented that “These two appointments are a powerful validation of 11 Health’s potential. The complimentary skills that these two such highly regarded individuals bring to 11 Health will accelerate the Company’s success in helping ostomy patients improve their health outcomes and quality of life.”