Pilot Project for the Treatment of Perianal Disease through the Local Injection of Remsima Guided by Ultrasound. Number of cases.

Marta Maia Boscá Watts0 个研究点目标入组 10 人开始时间: 2019年7月4日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•-Patients diagnosed with Crohn's disease with complex PD.
•-Older than 18 years-old.
•-EPA with no response, or partial response at the discretion of the clinician, to usual medical treatment and / or drainage of abscesses, treatment of fistulas and / or placement of perianal setons.
•-PD with less than two internal holes and three external holes.
•-PDAI> 4.
•- Absence of rectal involvement or mild endoscopic activity (SES-CD <5).
•- Willing to enter the study and sign the informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patients with PD not associated with IBD.
•-Patients with moderate or severe allergic reactions due to anti-TNF.
•-PD with more than two internal holes or three external holes.
•-Rectovaginal fistulas.
•-Moderate or severe proctitis.
•-Anal or rectal stenosis that prevents an endoscopic ultrasound.
•-Patients with more than two fistulous trajectories.
•-Patients with perianal abscesses not drained of more than 2 cm.
•-PDAI <4.
•-Patients receiving specific local treatments for perianal disease such as stem cell injection. It must have been more than a year since the patient was treated with stem cells to be included in this study.
•-Definitive ileostomy carrier.
•-Pregnancy or breastfeeding, or desire for it during next year.
•-Recent surgical treatment with advancement sleeve flaps or others that were not drainage and / or seton placement.
•-Any other condition that in the opinion of the investigator prevents the patient from completing the study.
•-Any other condition that reduces the life expectancy to less than 1 year, including knowledge of cancer.
•-Patients who do not accept their participation in the study and / or do not sign the informed consent document.

发起方

Marta Maia Boscá Watts