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 : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Procedure: Early Procedure: Late||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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, 2021|
|Estimated Study Completion Date :||June 1, 2022|
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).
Early ileostomy closure
Active Comparator: Late ileostomy closure
Late ileostomy closure will be performed 8 - 12 weeks after IPAA.
Late ileostomy closure
- 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).
- 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.)
- 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.
- 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.
- 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.
- 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
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
|Principal Investigator:||Jon Vogel, MD||University of Colorado, Denver|