Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery (NCT03587519) | Clinical Trial Compass
TerminatedNot Applicable
Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery
Stopped: Adverse Event
United States36 participantsStarted 2018-11-06
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sta…
What they're measuring
1
Comprehensive Complication Index at 6 months after randomization.