In patients with ulcerative or indeterminate colitis who undergo ileal pouch anal anastomosis and diverting loop ileostomy (IPAA) surgery\* a short interval to loop ileostomy reversal will result in differences in complications and quality of life compared to a long interval to loop ileostomy reversal.
Aim #1: To compare the Comprehensive Complication Index (CCI), the incidence of postoperative complications, including total number of complications per patient, percent of patients with complications, and total number of ostomy-related complications per patient among IPAA patients who have their ileostomy reversed after a short interval compared to a long interval. Aim #2: To compare the short vs. long interval groups on measures of health-related quality of life (PROMIS) and IPAA functional outcomes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Cedars Sinai
Los Angeles, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Northwestern University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Comprehensive Complication Index at 6 months after randomization.
The CCI® calculator is an online tool to support the assessment of patients' overall morbidity. The Comprehensive Complication Index (CCI®) is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).
Time frame: 6 months
Total number of postoperative complications per patient
Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.)
Time frame: 6 months
Percent of patients with complications
Percentage of patients with one or more postoperative complication such as surgical site infection, venous thromboembolism, lung or heart-related complications, etc.
Time frame: 1-2 month intervals after randomization through 6 months".
Total number of stoma related complications per patient
Examples: leakage, pain, retraction, prolapse, bleeding, etc.
Time frame: 1-2 month intervals after randomization through 6 months
Health-related quality of life
PROMIS questionnaire. This will be used to assess the study patient's overall health, quality of life, physical health, mental health, social activities, relationships, activities of daily living, emotional health, fatigue level, and pain.
Time frame: Once, at 6 months after ostomy closure surgery
IPAA functional outcomes
Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beth Israel
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Time frame: Once, at 6 months after ostomy closure surgery