Early Versus Delayed Surgery for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• with intestinal obstructive symptoms;
• confirmed intestinal strictures;
• traditional drugs failed to induce remission;
• envidence of active bowel inflammation;
• inappropriate for EBD;
• acquirement of written informed consent of participant;
Locations
Other Locations
China
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
RECRUITING
Nanjing
Contact Information
Primary
Weinming Zhu, Ph.D.
juwiming@nju.edu.cn
+86025-80860036
Time Frame
Start Date: 2022-06-09
Estimated Completion Date: 2030-06-01
Participants
Target number of participants: 138
Treatments
Other: Biologic group
If biologic(s) fails to provide relief, surgical intervention is considered. Following surgery, a prophylactic medication is offered based on the risk factors for recurrence
Other: Surgery group
treat paticipants with surgery and prophylactic medication according to the guidelines
Related Therapeutic Areas
Sponsors
Leads: Zhu Weiming