Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

NCT03587519 | Terminated DMC

• 1 other identifier: 17-0929
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 8

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.

Conditions

Ulcerative Colitis; Ileal Pouch; Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total number of postoperative complications per patient

  6 months

• Percent of patients with complications

  1-2 month intervals after randomization through 6 months".

• Total number of stoma related complications per patient

  1-2 month intervals after randomization through 6 months

• Health-related quality of life

  Once, at 6 months after ostomy closure surgery

• IPAA functional outcomes

  Once, at 6 months after ostomy closure surgery

Study Arms (2)

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).

Procedure: Early

Late ileostomy closure

ACTIVE COMPARATOR

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

Procedure: Late

Interventions

Early PROCEDURE

Early ileostomy closure

Early ileostomy closure

Late PROCEDURE

Late ileostomy closure

Late ileostomy closure

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (8)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Beth Israel

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 36627253 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jon Vogel, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 16, 2018
• Study Start: November 6, 2018
• Primary Completion: February 16, 2021
• Study Completion: March 31, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

US (8)