Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy

Prior treatment

• Prior enrolment in the current study.

Other illness

• End or loop colostomy, end ileostomy for UC, continent ileostomy, ileal pouch anal anastomosis, end ileostomy with mucous fistula, double barrel ileostomy, urostomy, loop ostomy, or any type of end ileostomy not considered permanent at the time of enrolment (with no intent to restore continuity).
• Any actively draining fistula (eg, peristomal or peri-anal).
• Known active Clostridoides difficile or other enteric infection.
• Short bowel syndrome.
• Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study procedures or provide nonconfounded descriptions of their CD and ostomy symptom experiences during the interview.

Other

• Peristomal skin complications such as pyoderma gangrenosum, abscess, or any other severe peristomal skin inflammation.
• Stomal stenosis obviating ileoscopy, known small bowel stricture, major stoma prolapse, symptomatic parastomal hernia, parastomal hernia with subcutaneous loops of small bowel within the hernia, stoma in a crease/poorly fitting applicable resulting in severe peristomal skin irritation, or retracted stoma that prevents endoscopic evaluation.
• Evidence of a known small bowel stricture on cross-sectional imaging or inability to pass an endoscope within the past 6 months.
• Predominant symptom(s) arising from a retained rectal stump.

• Adults (age ≥ 18 years) with a diagnosis of CD treated surgically with subtotal colectomy/proctocolectomy end ileostomy at least 12 months prior to the scheduled endoscopy procedure.
• Planning to have an ileoscopy procedure scheduled as part of routine medical care.
• Be proficient in the English language (ie, ability to read, write, speak, and understand English well enough to take part in the interview process without the aid of an interpreter).
• Able and willing to participate fully in all aspects of this study.
• Written informed consent must be obtained and documented.