Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery for Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 16
- 主要终点
- Comprehensive Complication Index at 6 months after randomization.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
结局指标
主要结局
Comprehensive Complication Index at 6 months after randomization.
时间窗: 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).
次要结局
- 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)
- Total number of postoperative complications per patient(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)