Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery (SLIRPS)

University of Colorado Denver (CU Denver)

Status

Terminated

Conditions

Ileal Pouch

Ileostomy - Stoma

Ulcerative Colitis

Treatments

Procedure: Early

Procedure: Late

Study type

Interventional

Funder types

Other

Identifiers

NCT03587519

17-0929

Details and patient eligibility

About

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.

Full 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

Enrollment

36 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.