NCT04865484

Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease.

Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease. Surgical Resection Plus Endoscopic Stricturotomy Versus Surgical Resection Plus Strictureplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Crohn Disease
• Stricture; Bowel

Interventions

Type	Name	Description
PROCEDURE	Surgical resection	Surgical resection of fibrostenotic area (\>4cm)
PROCEDURE	Endoscopic stricturotomy	Endoscopic stricturotomy of fibrostenotic area (≤4cm)
PROCEDURE	Strictureplasty	Strictureplasty of fibrostenotic area (≤4cm)

Timeline

• Start date: 2021-03-12
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-04-29
• Last updated: 2021-04-29

Locations

1 site across 1 country: China