Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- quality of life (QoL) by Inflammatory Bowel Disease Questionnaire
研究概览
简要总结
Compare the quality of life at 6 months between 2 populations of patients followed for terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.
详细描述
Two groups of patients suffering from Crohn's terminal ileitis will be matched by sex, age (A2, A3), the time evolution of the disease, the length of the diseased ileal segment (less than 10 cm; 10 to 30; 30 to 50 cm) and the Montreal classification (B1, B2). The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time. The surgical group are the patients operated on for the first time by means of ileocecal resection by laparoscopy or laparotomy without any severity criteria or perianal lesions and do not require prophylactic treatment of recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •isolated Crohn's ileitis without history of bowel resection and never previously been treated with anti-TNF
- •Men and woman over 18 years
- •Patient with social security cover
- •reapproved indication during multidisciplinary meeting
- •Patient able to receive clear information in written and oral
- •Informed consent signed by the patient
排除标准
- •Prophylactic treatment of recurrence before endoscopic control at the 6th postoperative month.
- •Contraindication to Anti-TNF after the initial lap works.
- •The side effects of surgery or anti-TNF are not exclusion criteria.
研究组 & 干预措施
medical treatment by Anti TNF
The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time
干预措施: Anti TNF (Drug)
ileocecal resection
The surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy
干预措施: ileocecal resection (Procedure)
结局指标
主要结局
quality of life (QoL) by Inflammatory Bowel Disease Questionnaire
时间窗: at 6 months from the beginning of medical treatment or surgical resection
comparing the quality of life (QoL) by Inflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patients followed for Crohn's terminal ileitis treated with anti-TNF or operated on by means of ileocecal resection
次要结局
- Duration of hospital stay(at baseline)
- Clavien-Dindo classification of surgical complications(at baseline, at 6 months)
- Inflammatory Bowel Disease Questionnaire (IBDQ)(at baseline (beginning of medical treatment or surgical resection), at 6 months)
- Length of small intestine segment resection(at baseline)
- Crohn's disease activity index (CDAI)(at baseline, at 6 months)