Endoscopic Relapse Risk Factors After Ileocolic Resection on Crohn's Disease Patients in the Biologic Era
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Endoscopic recurrence rate
研究概览
简要总结
Aim of the study:
To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents.
Methods:
From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected.
Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period.
Short and long-term outcomes were compared between the two groups.
Primary outcome:
Endoscopic recurrence (defined as > i2 lesions according to Rutgeerts classification) 6 months after surgery
详细描述
Crohn's disease is a chronic inflammatory bowel disease whose preferential location is the ileo-colon, for which surgical management is necessary in 60% of patients.
The most common surgical procedure is ileo-caecal resection for symptomatic last ileal loop stenosis resistant to a well conducted medical treatment.
The conventional surgical technique aims to preserve the length of the digestive tract as much as possible. From a technical point of view, the resection passes as close as possible to the small intestine, leaving the vessels within the mesentery in place.
Despite the improvement of therapeutics (over the last decade, 80% of patients present an endoscopic recurrence at 1 year after surgery. Endoscopic recurrence is defined as the apparition of new typical mucosal lesions based on the Rutgeerts classification.
According to the last ECCO guidelines, biologic agents (TNF-inhibitors, ustekinumab and vedolizumab) are used as maintenance treatment in moderate-to-severe Crohn's disease patients:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven Crohn's disease
- •On anti-TNF alpha: infliximab, adalimumab (ECCO 2014 recommendation)
- •> 18 years old patients
- •All patients who have undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat procedure)
排除标准
- •Minor patients under 18 years of age
- •Endoscopic follow-up not possible
- •Pregnant women
- •Medical treatment other than anti-TNF alpha
结局指标
主要结局
Endoscopic recurrence rate
时间窗: 6 months after surgery
Defined as the presenc of new mucosal lesions classified \>i2 according to Rutgeerts classification.
次要结局
- Mortality rate(90 days after surgery)
- Intra-operative blood loss(90 days after surgery)
- Length of resected specimen(90 days after surgery)
- Duration of surgery(90 days after surgery)
- Postoperative morbidity rate(90 days after surgery)
- Myenteric plexitis(90 days after surgery)
- Number of inflammatory cells in myenteric plexuses(90 days after surgery)
- Resection margins(90 days after surgery)