Post-operative Crohn's Endoscopic Recurrence Study (POCER)

University of Melbourne

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Procedure: endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00989560

HREC-A 077/09

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Active arm

Active Comparator group

Treatment:

Procedure: endoscopy

Standard care arm

No Intervention group