Ileal Pouch, Ileostomy - Stoma, Ulcerative Colitis
Conditions
Brief summary
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.
Detailed description
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
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consents. * Man or woman between 18 and 64 years of age. * Ulcerative colitis (UC) or indeterminate colitis (IC) diagnosed by routine clinical, radiographic, endoscopic, and pathological criteria. * Patient will be scheduled for non-emergent proctocolectomy or completion proctectomy with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA). * Clinical assessment of patient after IPAA surgery indicates that patient is suitable for early ileostomy reversal
Exclusion criteria
* Age \< 18 or \> 64 years * Colon or rectal cancer * Crohn's disease or suspected Crohn's disease * Prednisone dose \> 20 mg per day (or equivalent other steroid dose) within 4 weeks of scheduled IPAA * Body mass index (BMI) equal to or greater than 40 kg/m2 * Hemodynamic instability (persistent pulse rate \< 50 or \> 120 bpm, systolic blood pressure \< 90 or \> 160 mm Hg, uncontrolled cardiac arrhythmia, or active vasopressor drug use) * Organ transplant recipient (e.g. Liver, Kidney, Pancreas) * Immunosuppression due to chemotherapy drug use or systemic disease. * Sepsis * Renal insufficiency (i.e. serum creatinine ? 2 mg/dl or need for dialysis) * Therapeutic anticoagulation (e.g. venous thromboembolic disease, prosthetic heart valve) * Blood Hemoglobin \< 8 g/dl * Serum Albumin \< 2.5 g/dl * Individualized decision by the surgeon to exclude the patient based on sound surgical judgment * Pregnant patients and female patients who do not satisfy the standard of care requirements of participating centers for an elective surgical procedure. * Clinical assessment of patient after IPAA surgery indicates that patient is not suitable for early ileostomy reversal * Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial * Well-founded doubt about the patient's cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index at 6 months after randomization. | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of postoperative complications per patient | 6 months | Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.) |
| Percent of patients with complications | 1-2 month intervals after randomization through 6 months. | Percentage of patients with one or more postoperative complication such as surgical site infection, venous thromboembolism, lung or heart-related complications, etc. |
| Total number of stoma related complications per patient | 1-2 month intervals after randomization through 6 months | Examples: leakage, pain, retraction, prolapse, bleeding, etc. |
| Health-related quality of life | Once, at 6 months after ostomy closure surgery | 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. |
| IPAA functional outcomes | Once, at 6 months after ostomy closure surgery | Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use |
Countries
United States
Outcome results
None listed