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

Primary Purpose

Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early
Late
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cedars Sinai
  • University of Colorado Denver
  • Northwestern University Medical Center
  • University of Chicago
  • Beth Israel
  • University of Michigan
  • Washington University
  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early ileostomy closure

Late ileostomy closure

Arm Description

Early ileostomy closure will be performed 7 to 12 days after with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA).

Late ileostomy closure will be performed 8 - 12 weeks after IPAA.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Total number of postoperative complications per patient
Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.)
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.
Total number of stoma related complications per patient
Examples: leakage, pain, retraction, prolapse, bleeding, etc.
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.
IPAA functional outcomes
Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use

Full Information

First Posted
June 26, 2018
Last Updated
February 8, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03587519
Brief Title
Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery
Acronym
SLIRPS
Official Title
Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery for Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Adverse Event
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
February 16, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early ileostomy closure
Arm Type
Experimental
Arm Description
Early ileostomy closure will be performed 7 to 12 days after with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA).
Arm Title
Late ileostomy closure
Arm Type
Active Comparator
Arm Description
Late ileostomy closure will be performed 8 - 12 weeks after IPAA.
Intervention Type
Procedure
Intervention Name(s)
Early
Intervention Description
Early ileostomy closure
Intervention Type
Procedure
Intervention Name(s)
Late
Intervention Description
Late ileostomy closure
Primary Outcome Measure Information:
Title
Comprehensive Complication Index at 6 months after randomization.
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total number of postoperative complications per patient
Description
Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.)
Time Frame
6 months
Title
Percent of patients with complications
Description
Percentage of patients with one or more postoperative complication such as surgical site infection, venous thromboembolism, lung or heart-related complications, etc.
Time Frame
1-2 month intervals after randomization through 6 months".
Title
Total number of stoma related complications per patient
Description
Examples: leakage, pain, retraction, prolapse, bleeding, etc.
Time Frame
1-2 month intervals after randomization through 6 months
Title
Health-related quality of life
Description
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.
Time Frame
Once, at 6 months after ostomy closure surgery
Title
IPAA functional outcomes
Description
Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use
Time Frame
Once, at 6 months after ostomy closure surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Vogel, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Northwestern University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Beth Israel
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

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