Ulcerative ColitisSLIRPSNCT03587519
Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery
A study testing Early and Late in people with Ulcerative Colitis and Ileal Pouch, run by University of Colorado, Denver at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma
- What is being tested?
- Early and Late
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Nov 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Denver
Aurora, Colorado, 80045
Beth Israel
Boston, Massachusetts, 02215
Northwestern University Medical Center
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Cedars Sinai
Los Angeles, California, 90048
Washington University
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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
- Conditions
- Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma
- Being tested
- Early, Late
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarlyProcedure or surgery
Early ileostomy closure
LateProcedure or surgery
Late ileostomy closure
| Study group | Role | What they receive |
|---|---|---|
| Early ileostomy closure | Experimental | Early ileostomy closure will be performed 7 to 12 days after with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA). Receives: Procedure: Early |
| Late ileostomy closure | Active comparator | Late ileostomy closure will be performed 8 - 12 weeks after IPAA. Receives: Procedure: Late |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (5)
Total number of postoperative complications per patient
Post-operative complications. For example, surgical site infection, venous thromboembolism, lung or heart-related complications, etc.)
Measured: 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.
Measured: 1-2 month intervals after randomization through 6 months".
Total number of stoma related complications per patient
Examples: leakage, pain, retraction, prolapse, bleeding, etc.
Measured: 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.
Measured: Once, at 6 months after ostomy closure surgery
IPAA functional outcomes
Daily stools, nightly stools, stool seepage, stool incontinence, anti-peristaltic medication use
Measured: Once, at 6 months after ostomy closure surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start6 Nov 2018
- Primary completion16 Feb 2021
- Study completion31 Mar 2021
Why it stopped: Adverse Event
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Vogel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587519
- Sponsor's protocol ID
- 17-0929
- Acronym
- SLIRPS
- Status last verified
- Feb 2022
- First submitted
- 26 Jun 2018
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vogel JD, Fleshner PR, Holubar SD, Poylin VY, Regenbogen SE, Chapman BC, Messaris E, Mutch MG, Hyman NH. High Complication Rate After Early Ileostomy Closure: Early Termination of the Short Versus Long Interval to Loop Ileostomy Reversal After Pouch Surgery Randomized Trial. Dis Colon Rectum. 2023 Feb 1;66(2):253-261. doi: 10.1097/DCR.0000000000002427. Epub 2023 Jan 6.
PubMed 36627253
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03587519
- Acronym / sponsor ID
- SLIRPS / 17-0929
- Conditions
- Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse Event
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early ileostomy closure | Experimental | Procedure: EarlyEarly ileostomy closure will be performed 7 to 12 days after with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA). |
| Late ileostomy closure | Active comparator | Procedure: LateLate ileostomy closure will be performed 8 - 12 weeks after IPAA. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarlyEarly ileostomy closure | Procedure or surgery | Early ileostomy closure |
| LateLate ileostomy closure | Procedure or surgery | Late ileostomy closure |
Primary outcome
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).
5 secondary outcomes
Total number of postoperative complications per patient
Time frame: 6 months
Percent of patients with complications
Time frame: 1-2 month intervals after randomization through 6 months".
Total number of stoma related complications per patient
Time frame: 1-2 month intervals after randomization through 6 months
Health-related quality of life
Time frame: Once, at 6 months after ostomy closure surgery
IPAA functional outcomes
Time frame: Once, at 6 months after ostomy closure surgery
Results and safety
The study was stopped early (reason given: Adverse Event). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 36627253Vogel JD, Fleshner PR, Holubar SD, Poylin VY, Regenbogen SE, Chapman BC, Messaris E, Mutch MG, Hyman NH. High Complication Rate After Early Ileostomy Closure: Early Termination of the Short Versus Long Interval to Loop Ileostomy Reversal After Pouch Surgery Randomized Trial. Dis Colon Rectum. 2023 Feb 1;66(2):253-261. doi: 10.1097/DCR.0000000000002427. Epub 2023 Jan 6.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Vogel, MD principal investigator
University of Colorado, Denver
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early and Late in people with Ulcerative Colitis and Ileal Pouch, run by University of Colorado, Denver at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Adverse Event). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index at 6 months after randomization. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03587519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.