Post-operative Crohn's Endoscopic Recurrence Study

NCT ID: NCT00989560

Last Updated: 2014-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Active arm

Group Type ACTIVE_COMPARATOR

endoscopy

Intervention Type PROCEDURE

patients receive best treatment and care with an additional endoscopy

Standard care arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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endoscopy

patients receive best treatment and care with an additional endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Michael Kamm

Professorial Fellow, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael A Kamm, MBBS MD FRCP FRACP

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital, Melbourne; University of Melbourne

Peter De Cruz, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital, Melbourne; University of Melbourne

Locations

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St Vincent's Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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Teh JJ, Berendsen EM, Hoedt EC, Kang S, Zhang J, Zhang F, Liu Q, Hamilton AL, Wilson-O'Brien A, Ching J, Sung JJY, Yu J, Ng SC, Kamm MA, Morrison M. Novel strain-level resolution of Crohn's disease mucosa-associated microbiota via an ex vivo combination of microbe culture and metagenomic sequencing. ISME J. 2021 Nov;15(11):3326-3338. doi: 10.1038/s41396-021-00991-1. Epub 2021 May 25.

Reference Type DERIVED
PMID: 34035441 (View on PubMed)

Wright EK, Kamm MA, Dr Cruz P, Hamilton AL, Ritchie KJ, Bell SJ, Brown SJ, Connell WR, Desmond PV, Liew D. Cost-effectiveness of Crohn's disease post-operative care. World J Gastroenterol. 2016 Apr 14;22(14):3860-8. doi: 10.3748/wjg.v22.i14.3860.

Reference Type DERIVED
PMID: 27076772 (View on PubMed)

Wright EK, Kamm MA, De Cruz P, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Sparrow MP, Florin TH, Gibson PR, Debinski H, Gearry RB, Macrae FA, Leong RW, Kronborg I, Radford-Smith G, Selby W, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Desmond PV. Effect of intestinal resection on quality of life in Crohn's disease. J Crohns Colitis. 2015 Jun;9(6):452-62. doi: 10.1093/ecco-jcc/jjv058. Epub 2015 Apr 8.

Reference Type DERIVED
PMID: 25855073 (View on PubMed)

Wright EK, Kamm MA, De Cruz P, Hamilton AL, Ritchie KJ, Krejany EO, Leach S, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Jakobovits SL, Florin TH, Gibson PR, Debinski H, Macrae FA, Samuel D, Kronborg I, Radford-Smith G, Selby W, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Day AS, Desmond PV, Gearry RB. Measurement of fecal calprotectin improves monitoring and detection of recurrence of Crohn's disease after surgery. Gastroenterology. 2015 May;148(5):938-947.e1. doi: 10.1053/j.gastro.2015.01.026. Epub 2015 Jan 22.

Reference Type DERIVED
PMID: 25620670 (View on PubMed)

De Cruz P, Kamm MA, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Gibson PR, Sparrow M, Leong RW, Florin TH, Gearry RB, Radford-Smith G, Macrae FA, Debinski H, Selby W, Kronborg I, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Desmond PV. Crohn's disease management after intestinal resection: a randomised trial. Lancet. 2015 Apr 11;385(9976):1406-17. doi: 10.1016/S0140-6736(14)61908-5. Epub 2014 Dec 24.

Reference Type DERIVED
PMID: 25542620 (View on PubMed)

Other Identifiers

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HREC-A 077/09

Identifier Type: -

Identifier Source: org_study_id

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