J-Pouch Patient Studies Establish First Outcome Measures

Massachusetts General Hospital physicians are establishing the first comprehensive set of patient-centric functional outcomes measures for patients undergoing J-pouch surgery for ulcerative colitis (UC).

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After identifying and analyzing knowledge gaps in their work with post-surgical patients (published in Diseases of the Colon and Rectum), Liliana Bordeianou, MD, MPH, professor of Surgery at Harvard Medical School and site director of Mass General Colorectal Surgery, and resident Paul Cavallaro, MD, worked to fully catalog health- and quality-of-life-impacting symptoms experienced by patients living with ileoanal pouches. Their efforts will create an internationally accepted clinical scoring system for ileoanal pouch syndrome: A constellation of symptoms that represent the daily function experienced by patients following surgery, some of them impacting patient health and quality-of-life. This standardized system will be available in the clinic and for future research involving surgical improvements and treatments for post-surgical complications.

"Our initial pilot study showed that while most patients are ultimately satisfied with their surgery, 10%–15% face significant post-surgical struggles," says Dr. Bordeianou. "Young people have to live the rest of their lives with the results of ulcerative colitis treatment. Our aim through these series of research projects and quality improvement initiatives is the capture of valid outcomes measures and the creation of a culture of survivorship to support them."

Lack of Patient-focused Outcomes Measures

An estimated 23%–45% of ulcerative colitis patients will undergo J-pouch surgery—which is widely perceived to be curative. The J-pouch procedure removes the colon and recreates its anatomic configuration with loops of small intestine.

While most colorectal surgeons perform ileoanal pouch surgery, UC is rare enough that few surgeons see significant volume. When enough volume does exist, data has focused on surgeon-identified outcomes measures, such as fecal incontinence and bowel movement frequency.

"The lack of patient perspectives is significant," says Dr. Cavallaro, who has worked extensively to craft a study that appropriately weighs patient feedback. He notes that recent research on outcomes most impactful to patients reflects a wide divergence in patient and surgeon perspectives. In this climate, complications that negatively impact patient health and quality-of-life remain unaddressed.

Post-surgical Complication Knowledge Gaps

Dr. Bordeianou initiated her first pilot study to evaluate possible patient complaints about bowel function following ileoanal pouch surgery. She noted that patients reported several unrecognized symptoms, published in Diseases of the Colon and Rectum.

While the single-center study cataloged many previously unidentified or under-identified issues, Drs. Bordeianou and her team determined that additional data was needed to fully classify symptoms.

"Patient stories about their post-surgical self-perception, sexual function, intimacy and alteration of life choices drove the development of a comprehensive multicenter Delphi study," says Dr. Bordeianou.

Study Establishes Functional and Quality of Life Symptoms Relevant to Both Patients and Providers

The Delphi consensus method allowed researchers to synthesize complex and divergent feedback from both clinician and patient stakeholders. Investigators delved into complex questions surrounding bowel function and its impact on patients, clarifying and refining responses over three survey phases.

In total, 195 patients, 62 colorectal surgeons, and 48 gastroenterologists and/or nurse specialists completed all three of the Delphi survey phases. As a result, seven bowel symptoms and seven consequences of undergoing ileoanal pouch surgery were included in the final consensus statement.

Symptoms

1. Fecal incontinence
2. Soiling
3. Urgency
4. Frequency
5. Clustering and fragmentation
6. Uncomfortable perianal symptoms
7. Nocturnal symptoms

Consequences

1. Pad usage
2. Toilet awareness
3. Dietary and medical adjustments
4. Alternations in sleep and energy
5. Negative impact on intimacy
6. Alterations in social roles
7. Negative mental, emotional and psychological alterations

Clinical Scoring System

Armed with the list of relevant symptoms that are extremely important to patients, Dr. Bordeianou' s team is currently in the third stage of research with an international study aimed at producing a globally applicable clinical scoring system for ileoanal pouch function. Tripartite organizations of colorectal surgeons in the United States, United Kingdom, Europe, New Zealand and Australia are encouraging patients to participate in a team effort with the Crohn's and Colitis Foundation.

The ultimate pouch scoring system should be a key pillar for additional research into:

• Surgery timing and approaches to improve function
• Medication prescriptions pre- and post-surgery
• Probiotic use
• Monitoring and follow-up care
• Survivorship support

"There are endless possibilities for research that will drive improvements. A validated J-pouch syndrome measurement tool will enable it," says Dr. Bordeianou.

New J-Pouch Center Supports Survivorship

To better address patient outcomes post-surgery, Mass General will also open a new J-Pouch Center later this year. A gastrointestinal specialist will lead it in collaboration with Mass General's Colorectal Surgery Program. Dr. Bordeianou believes these actions will create a culture of survivorship for patients living with benign disease.

"Throughout this research, many patients spoke about struggling alone through 'multiple reincarnations of themselves' to get to normalcy," says Dr. Bordeianou. "Patients will now have a touchstone with clinical support and the ability to share their successes with others."

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