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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis; Ileostomy - Stoma; Ileal Pouch
• Intervention / Treatment: Procedure: Early; Procedure: Late

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early ileostomy closure; Early ileostomy closure will be performed 7 to 12 days after with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA).	Procedure: Early; Early ileostomy closure
Active Comparator: Late ileostomy closure; Late ileostomy closure will be performed 8 - 12 weeks after IPAA.	Procedure: Late; Late ileostomy closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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".
Total number of stoma related complications per patient	Examples: leakage, pain, retraction, prolapse, bleeding, etc.	1-2 month intervals after randomization through 6 months
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
IPAA functional outcomes	Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use	Once, at 6 months after ostomy closure surgery

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jon Vogel, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): February 16, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 17-0929

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No