Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

Stopped early · Not applicable

Conditions studied: Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma

In brief

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.

Key facts

Study ID

NCT03587519

Run by

University of Colorado, Denver

People needed

36

Starts

2018-11-06

Expected to finish

2021-03-31

Last updated by the study team

2022-03-04

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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