Post-operative Crohn's Endoscopic Recurrence Study

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopy

Procedure

patients receive best treatment and care with an additional endoscopy

Primary outcomes

Endoscopic recurrence of disease

Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Registry information

Official study title

Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause

Acronym: POCER

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Oct 5, 2009
Registry last updated: Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed