Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US): Multicentric, Observational and Cross-sectional Comparison Study With Colonoscopy in a Cohort of IBD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correlation of data
研究概览
简要总结
At enrollment, after informed consent form will be discussed and signed, subjects will undergo complete disease assessment.
In this study, 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital (50 patients with Crohn's disease, 50 with Ulcerative colitis not undergoing proctocolectomy, and 50 with Ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis).
All the patients will perform routine investigations with Ileocolonoscopy (IC), according to the current standard of care indications and ECCO guidelines, and they will be assessed by both Intestinal Ultrasound (IUS) and Trans-perineal ultrasound (TPUS). Blood and stool samples will be obtained for fecal calprotectin (FC) and C-reactive protein (CRP) measurements, respectively, as normal clinical practice.
All the procedures of this study are performed routinely in clinical practice. All the procedures are performed in a single day-visit for the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Confirmed diagnosis of IBD for at least 3 months, in particular 50 with Crohn&;s disease (CD), 50 with ulcerative colitis (UC) not undergoing proctocolectomy, 50 with ulcerative colitis (UC) undergoing proctocolectomy with ileal pouch-anal anastomosis
- •Performing ileocolonoscopy, according to current standards of care and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice
- •Ability to understand and comply with the study procedure and sign an informed consent form
排除标准
- •Pregnancy;
- •Concomitant intestinal infection (e.g. Clostridium difficile);
- •Cirrhosis or intra-abdominal ascites.
- •Subjects not able to comply with any study procedure;
- •Subjects not able to understand and give informed consent form;
- •Subjects with any contraindication to any study procedure.
结局指标
主要结局
correlation of data
时间窗: 1 day (Cross Sectional study)
To correlate ultrasound finding, both transabdominally and transperineally, with endoscopic findings
次要结局
未报告次要终点
研究者
Mariangela Allocca
M.D, PhD
IRCCS San Raffaele