Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

Ulcerative Colitis Clinical Trial

— SLIRPS  

Official title:

Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery for Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03587519
• Other study ID #: 17-0929
• Status: Terminated
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: March 31, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ileal Pouch
• Ileostomy - Stoma
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Early
Early ileostomy closure
• Late
Late ileostomy closure

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado Denver	Aurora	Colorado
United States	Beth Israel	Boston	Massachusetts
United States	Northwestern University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cedars Sinai	Los Angeles	California
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehensive Complication Index at 6 months after randomization.	The CCI® calculator is an online tool to support the assessment of patients' overall morbidity. The Comprehensive Complication Index (CCI®) is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).	6 months
Secondary	Total number of postoperative complications per patient	Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.)	6 months
Secondary	Percent of patients with complications	Percentage of patients with one or more postoperative complication such as surgical site infection, venous thromboembolism, lung or heart-related complications, etc.	1-2 month intervals after randomization through 6 months".
Secondary	Total number of stoma related complications per patient	Examples: leakage, pain, retraction, prolapse, bleeding, etc.	1-2 month intervals after randomization through 6 months
Secondary	Health-related quality of life	PROMIS questionnaire. This will be used to assess the study patient's overall health, quality of life, physical health, mental health, social activities, relationships, activities of daily living, emotional health, fatigue level, and pain.	Once, at 6 months after ostomy closure surgery
Secondary	IPAA functional outcomes	Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use	Once, at 6 months after ostomy closure surgery