Short or Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

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

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.