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

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ClinicalTrials.gov Identifier: NCT03587519
Recruitment Status : Enrolling by invitation
First Posted : July 16, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Procedure: Early Procedure: Late Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Versus Long Interval to Loop Ileostomy Reversal After Ileal Pouch Surgery in Patients With Ulcerative Colitis (SLIRPS) Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Comprehensive Complication Index at 6 months after randomization. [ Time Frame: 6 months ]
    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).


Secondary Outcome Measures :
  1. Total number of postoperative complications per patient [ Time Frame: 6 months ]
    Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.)

  2. Percent of patients with complications [ Time Frame: 1-2 month intervals after randomization through 6 months". ]
    Percentage of patients with one or more postoperative complication such as surgical site infection, venous thromboembolism, lung or heart-related complications, etc.

  3. Total number of stoma related complications per patient [ Time Frame: 1-2 month intervals after randomization through 6 months ]
    Examples: leakage, pain, retraction, prolapse, bleeding, etc.

  4. Health-related quality of life [ Time Frame: Once, at 6 months after ostomy closure surgery ]
    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.

  5. IPAA functional outcomes [ Time Frame: Once, at 6 months after ostomy closure surgery ]
    Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587519


Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California
Irvine, California, United States, 92697
Cedars Sinai
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Florida
Cleveland Clinic
Weston, Florida, United States, 33331
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massuchusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
New York University
New York, New York, United States, 10006
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
United States, Texas
Baylor University
Dallas, Texas, United States, 76798
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jon Vogel, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03587519     History of Changes
Other Study ID Numbers: 17-0929
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases