Comparing Endoscopic and Surgical Treatments for New Narrowing in Crohns Disease A Prospective Multicenter Randomized Study

What this Trial Is About

Crohns disease CD often leads to stenosis, a common complication that increases risks like repeated surgery and short bowel syndrome. This study focuses on patients with new de novo stenosis less than 10 cm in length, seeking to compare the effectiveness, complications, quality of life impact, and costs of surgical versus endoscopic treatments. There is currently no clear scientific evidence guiding the best treatment choice for these patients. The study compares two endoscopic treatmentsendoscopic balloon dilation EBD and self-expanding metal stents SEMSagainst surgical resection for managing de novo stenosis in CD. Participants in the endoscopic groups receive either pneumatic balloon dilations up to twice with intervals or placement of fully coated metal stents for four weeks. Surgical resection is also evaluated, with all procedures including post-procedural monitoring in a Short Stay Unit and sedation as appropriate. Participants will be followed for one year, during which their quality of life, clinical recurrence, and complications will be assessed. Evaluations include endoscopic and radiological tests to confirm stenosis and ongoing monitoring of symptoms. The study also considers treatment costs and long-term efficacy. The overall aim is to better understand which treatment approach offers the best balance of safety, effectiveness, quality of life, and cost for patients with CD-related stenosis.

Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.