Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with multi segmental intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection. Strictureplasty conserves bowel and minimizes the risk of developing short-bowel syndrome in the short-term and, probably, long-term. Strictureplasty has become an established surgical option in the management of obstructive Crohn's disease, especially for multiple short fibrous strictures. It is particularly suitable for patients at risk for short-bowel syndrome. Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The ECCO guideline recommended that endoscopic balloon dilatation is suitable to treat short \[\<5 cm\] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation. However, there is no scientific evidence for determining the most appropriate treatment for multiple fibrosis stenosis. We designed a prospective randomized comparative study of the treatment of multisegmental fibrostenosing Crohn's disease (surgical resection plus endoscopic stricturotomy versus surgical resection plus strictureplasty).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Surgical resection of fibrostenotic area (\>4cm)
Endoscopic stricturotomy of fibrostenotic area (≤4cm)
Strictureplasty of fibrostenotic area (≤4cm)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGIntervention-free survival
Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence
Time frame: 52 weeks
Surgery-free survival
Percentage of patients who do not receive surgical intervention for obstruction recurrence
Time frame: 52 weeks
Obstructive score reduction
Obstructive score reduction compared to baseline
Time frame: Week 4、12、20、28、36、44、52
CDAI score reduction
CDAI score reduction compared to baseline
Time frame: Week 4、12、20、28、36、44、52
IBDQ score reduction
IBDQ score reduction compared to baseline
Time frame: Week 4、12、20、28、36、44、52
Adverse event rate
Percentage of adverse events
Time frame: 52 weeks
Total cost for intervention
Total cost for intervention
Time frame: 52 weeks
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