Clinical trial NCT03587519: Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery
Official title: Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcerative Colitis
Ileal Pouch
Ileostomy - Stoma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Comprehensive Complication Index at 6 months after randomization.
timeFrame: 6 months
Secondary outcomes:
measure: Total number of postoperative complications per patient
timeFrame: 6 months
measure: Percent of patients with complications
timeFrame: 1-2 month intervals after randomization through 6 months".
measure: Total number of stoma related complications per patient
timeFrame: 1-2 month intervals after randomization through 6 months
measure: Health-related quality of life
timeFrame: Once, at 6 months after ostomy closure surgery
measure: IPAA functional outcomes
timeFrame: Once, at 6 months after ostomy closure surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Beth Israel
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: University of Colorado, Denver
name: Jon Vogel, MD
role: PRINCIPAL_INVESTIGATOR
References: