RecruitingNot ApplicableNCT05421455

Early vs Delayed Surgery for Stricturing CD--a RCT

Early Versus Delayed Surgery for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial


Sponsor

Zhu Weiming

Enrollment

138 participants

Start Date

Jun 9, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing surgery versus biologic medications (targeted immune therapies) for people with Crohn's disease who have developed a narrowing (stricture) in the intestine that is blocking normal digestion. Both approaches are used in practice, and this trial aims to determine which leads to better outcomes. **You may be eligible if...** - You have Crohn's disease with confirmed intestinal narrowing (stricture) causing bowel obstruction symptoms - You have active bowel inflammation alongside the stricture - Standard medications (like steroids or immunomodulators) have not worked - The stricture cannot be safely treated with endoscopic balloon dilation (EBD) - You are willing and able to provide written consent **You may NOT be eligible if...** - Your stricture can be managed with endoscopic dilation - You have a bowel perforation, fistula, or abscess requiring urgent surgery - You have a serious infection or other condition making surgery or biologic treatment unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGroup A

treat participants with biologics

PROCEDUREGroup B

treat participants with surgery


Locations(1)

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Nanjing, Jiangsu, China

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NCT05421455


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