Sphincter preserving surgery is increasingly being performed for rectal cancer, offering a cure while allowing patients to avoid a permanent colostomy. However, up to 70% of rectal cancer survivors who undergo a partial or total resection of the rectum experience a distressing group of bowel-related symptoms referred to as low anterior resection syndrome (LARS).
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“There is no standard treatment for LARS and limited resources to help patients self-manage their symptoms, especially during the first three months after restoration of GI continuity, following the removal of their temporary ileostomies,” explains colorectal surgeon Marylise Boutros, MD, Director of Research for Cleveland Clinic’s Digestive Disease Institute in Florida.
Dr. Boutros is leading a team of researchers with Cleveland Clinic in Florida and McMaster University in Ontario, Canada, in a collaboration to develop a LARS-AI tool that can provide patients with real-time education on self-management strategies for their symptoms.
The project, entitled The Feasibility and Impact of an Artificial Intelligence Platform for the Management of Low Anterior Resection Syndrome: A Prospective Pilot Study, was recently awarded a 2024 Research Grant through the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Education & Research Foundation.
Symptoms associated with LARS include fecal incontinence, urgency, frequency, clustering of bowel movements, and painful evacuation. They can vary in severity by patient and their respective cancer and course of treatment.
“Patients can suffer with bowel symptoms for well over a decade following resection, often without any resources to support them,” says Dr. Boutros. “This can lead to anxiety, isolation and an overall decrease in quality of life.”
An international expert in LARS-focused clinical research and care, Dr. Boutros has been a passionate advocate for rectal cancer survivors since completing her colorectal surgery residency and fellowship training at Cleveland Clinic Weston Hospital more than a decade ago.
“What I’ve observed in my years as a surgeon is that we are doing a great job curing patients of their cancer but not preparing them for their ‘new’ life after treatment,” says Dr. Boutros, noting she’s seen patients unable to return to work due to their disordered bowel function.
Symptom management for LARS typically includes lifestyle and pharmacological strategies, such as dietary restrictions, stool bulking agents, and anti-diarrheal medications. Other possible interventions may include pelvic floor rehabilitation, sacral neuromodulation, and transanal irrigation (TAI).
Dr. Boutros points out that TAI, a procedure where patients flush out their entire colon on a regular basis at home, is not widely used in the U.S., though it is part of the management guidelines put forward by an international team of LARS experts in 2021. As principal investigator of a Canada-based trial, she is currently evaluating the impact of TAI on quality of life in rectal cancer survivors living with LARS and expects to publish her findings in the coming year.
“We are still in the early days of learning to manage postoperative bowel dysfunction, and our tools are limited,” shares Dr. Boutros. “Our hope for the web-based AI platform we are developing is that we can put the best information we have into the hands of all patients struggling with LARS no matter where they are receiving care.”
The LARS-AI intervention will use narrow AI with natural language processing (NLP) to interpret patient queries and create tailored responses in real-time based on a database of clinical scenarios and expert advice.
“This differs from a generative AI model that creates responses,” explains Dr. Boutros. “Instead it will retrieve an appropriate response aligned with established best practices from the scenarios we compile through our research.”
The team has partnered with a software developer to build the framework for the LARS-AI platform. The next step will be to create the database of more than 500 detailed LARS scenarios based on patient interviews, a LARS expert survey, and prior LARS research data compiled by Dr. Boutros and her colleagues.
The second phase of the research will consist of a multi-center single-arm prospective cohort pilot study to evaluate the feasibility and impact of the LARS-AI platform. Participants will be adult patients who have undergone restorative proctectomy and have major LARS. They will be recruited from the high-volume colorectal surgery practices at Cleveland Clinic Weston Hospital and McMaster University-affiliated Juravinski Hospital in Hamilton, Ontario.
Study participants will have access to the LARS-AI platform for two months. During this time, researchers will collect data on the platform’s engagement, acceptability, and usability as well as assess its impact on symptom change, quality of life, and bowel function through self-reported validated questionnaires at baseline, one month, and two months.
“Based on our initial findings, we will conduct a larger effectiveness multicenter randomized control trial,” says Dr. Boutros.
The LARS-AI study is co-led by Olivia Monton, MD, a third-year general surgery resident at McMaster University. Dr. Monton has worked with Dr. Boutros in a mentor-mentee capacity since 2018, as a medical student at McGill University in Montreal, Canada, where Dr. Boutros served as a Professor of Surgery.
Together they developed an online educational and supportive care application (eLARS) for patients with LARS and their caregivers. It was evaluated through a multicenter clinical trial, and the results were accepted for podium presentation at this year’s SAGES Annual Meeting in Cleveland, Ohio.
Another research initiative led by Dr. Boutros included the development of an educational booklet on LARS as part of a LARS Patient-Centered Program to educate individuals with rectal cancer about postoperative bowel dysfunction, help manage expectations, and review the different treatment strategies. It, too, is currently being evaluated through an ongoing clinical trial.
“The LARS-AI tool we are now developing builds upon our previous research and is the next step in empowering patients to self-manage their symptoms, alongside their clinical care team, and regain their quality of life as rectal cancer survivors,” says Dr. Boutros.
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