Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery for Ulcerative Colitis

Conditions
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Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma

Intervention / Treatment
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* Procedure: Early
* Procedure: Late


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early ileostomy closure<br>Early ileostomy closure will be performed 7 to 12 days after with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA). | Procedure: Early<br>* Early ileostomy closure<br>|
| Active Comparator: Late ileostomy closure<br>Late ileostomy closure will be performed 8 - 12 weeks after IPAA. | Procedure: Late<br>* Late ileostomy closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of postoperative complications per patient | Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.) | 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. | 1-2 month intervals after randomization through 6 months. | 
| Total number of stoma related complications per patient | Examples: leakage, pain, retraction, prolapse, bleeding, etc. | 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. | Once, at 6 months after ostomy closure surgery | 
| IPAA functional outcomes | Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use | Once, at 6 months after ostomy closure surgery |