An interventional study of Surgical resection and Endoscopic stricturotomy in Crohn Disease and Stricture; Bowel, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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).
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
Surgical resection plus endoscopic stricturotomy for multiple fibrous stenosis
Procedure: Surgical resection · Procedure: Endoscopic stricturotomy
Surgical resection plus strictureplasty for multiple fibrous stenosis
Procedure: Surgical resection · Procedure: Strictureplasty
Surgical resection of fibrostenotic area (\>4cm)
Endoscopic stricturotomy of fibrostenotic area (≤4cm)
Strictureplasty of fibrostenotic area (≤4cm)
Intervention-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
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Sixth Affiliated Hospital, Sun Yat-sen University