Early Versus Late Biologic Therapy for Post-operative Perforated Crohn's Disease Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- fecal fistula
研究概览
简要总结
crohn's disease patients who present by intestinal perforation as the first presentation are hard to deal with. Surgical techniques as anastmosis or diversion stoma and active course of the disease may greatly affect the quality of life. In post-operative period, is the priority to avoid the post operative complications and to improve surgical outcomes or to stop active course of the disease and to induce remission?. So, those patients were classified into two groups. one group received biological therapy early post operative and the other group received it 2 or 3 months later after surgery and the investigators will compare results between the two groups.
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
- •patients at or above 18 years old
- •patients with perforated bowel diagnosed as Crohn's disease at presentation underwent surgery
排除标准
- •patients less than 18 years old
- •well known Crohn's disease patients on medical treatment
- •associated bowel disease as malignancy and diverticulosis.
研究组 & 干预措施
post operative Crohn's patients
干预措施: early biologic therapy (Biological)
post operative Cronn's patients
干预措施: late biologic therapy (Biological)
结局指标
主要结局
fecal fistula
时间窗: from the first post-operative day to 2 months postoperatively
if found, its amount will be calculated per day using calibrated colostomy bag
size of intra-abdominal fluids or collection
时间窗: from the first post-operative day to 2 months postoperatively
size of peritoneal fluids will be measured by surface area in centimeter square ( weight x height) using ultrasound
bowel function
时间窗: from the first post-operative day to 2 months postoperatively
bowel function will be assessed by hearing intestinal sound using Stethoscope
sex
时间窗: 2 hours before surgery
sex of patients (male or female) will be recorded
skin maceration
时间窗: from the first post-operative day to 2 months postoperatively
skin maceration surface area will be calculated by (weight x height) in centimeter square using a ruler
body weight
时间窗: from the first post-operative day to 2 months postoperatively
weight gain or weight loss will be measured in kg
age
时间窗: 2 hours before surgery
age in years will be recorded
次要结局
未报告次要终点
研究者
Reham Zakaria Mohamed Ahmed
lecturer of general surgery
Zagazig University