Short or Long Interval to Ileostomy Reversal After Ileal Pouch Surgery



Status:Enrolling by invitation
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 64
Updated:12/1/2018
Start Date:October 1, 2018
End Date:June 1, 2020

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Short Versus Long Interval to Loop Ileostomy Reversal After Ileal Pouch Surgery in Patients With Ulcerative Colitis (SLIRPS) Trial

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

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.
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5801 South Ellis Avenue
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Principal Investigator: Neil Hyman, MD
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Chapel Hill, North Carolina 27599
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