Evaluation of the Efficacy and Safety of Endoscopic Dilatation Combined With Biological Therapy Therapy for the Treatment of Intestinal Stenosis in Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation
研究概览
简要总结
All patients with Crohn's disease, already undergoing biological therapy for the treatment of clinically significant intestinal stenosis and/or already undergoing endoscopic balloon dilatation during the period January 2016 - June 2024 will be enrolled.
详细描述
All patients meeting all inclusion criteria and no exclusion criteria will be offered participation in the study upon presentation of the information form and signing of the informed consent for participation in the study. Each patient will be assigned a progressive identification number (ID).
All clinical data will be recorded for all patients:
- Demographic data (age, sex, smoking habits)
- Montreal classification;
- Duration of disease;
- History of previous surgery;
- Past and current drug therapy.
All available data on stenosis characteristics will be recorded:
- Localisation (ileal, ileo-caecal, colic, anastomotic);
- Extent (mm);
- Evidence of concurrent endoscopic disease activity locally
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years,
- •Confirmed diagnosis of Crohn's disease;
- •Radiological or endoscopic evidence of Crohn's disease complicated by clinically significant intestinal stenosis treated by endoscopic balloon dilatation.
- •Minimum 12-month clinical follow-up at this hospital;
- •Ability to express and give informed consent for participation in the study and to adhere to the timetable of scheduled visits.
排除标准
- •Age <18 years;
- •Patients with pouch or terminal ileostomy;
- •Any clinical condition that, in the opinion of the investigators, may contraindicate enrolment in the study;
- •Unstable personality or inability to adhere to protocol procedures;
- •Inability to express and give informed consent for study participation and to adhere to the participation in the study and to adhere to the timing of the planned visits.
结局指标
主要结局
Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation
时间窗: 12 months
Measurement of the percentage of patients with Crohn's disease and intestinal stenosis who obtain a transitable colonoscopy after 12 months of follow-up, comparing two interventions: single biological therapy vs. endoscopic dilatation combined with biological therapy. Transitability of the colonoscopy will be determined by the ability of the colonoscope to completely pass through the stenosis as documented in the endoscopic and/or radiological reports. Data will be aggregated as the proportion of patients with transitable colonoscopy in the total number of patients in each treatment group.
次要结局
未报告次要终点