Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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

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Ulcerative Colitis Ileal Pouch Ileostomy - Stoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Early

Intervention Type PROCEDURE

Early ileostomy closure

Late ileostomy closure

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

Group Type ACTIVE_COMPARATOR

Late

Intervention Type PROCEDURE

Late ileostomy closure

Interventions

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Early

Early ileostomy closure

Intervention Type PROCEDURE

Late

Late ileostomy closure

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No