Post-operative Crohn's Endoscopic Recurrence Study

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Procedure: endoscopy

• Registration Number: NCT00989560
• Lead Sponsor: University of Melbourne

Brief Summary

This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint is the severity of endoscopic recurrence. In addition, tissue will be collected for microbiological and immunological analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• clinical diagnosis of Crohn's and proven history of disease
• patient undergone surgical resection with creation of a primary anastomosis

Exclusion Criteria

• endoscopically inaccessible anastomosis by standard colonoscopy
• presence of an end stoma
• pregnancy
• suspected perforation of the gastrointestinal tract
• presence of certain unsuitable comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active arm	endoscopy	-

Primary Outcome Measures

Name	Time	Method
Endoscopic recurrence of disease	18 months

Trial Locations

Locations (1)

St Vincent's Hospital; 🇦🇺 Melbourne, Victoria, Australia