Crohn's DiseasePhase 3POCERNCT00989560
Post-operative Crohn's Endoscopic Recurrence Study
A Phase 3 study testing endoscopy in people with Crohn's Disease, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2009to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Crohn's and proven history of disease
- patient undergone surgical resection with creation of a primary anastomosis
Who cannot join
- endoscopically inaccessible anastomosis by standard colonoscopy
- presence of an end stoma
- pregnancy
- suspected perforation of the gastrointestinal tract
- presence of certain unsuitable comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause
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.
- Conditions
- Crohn's Disease
- Being tested
- endoscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyProcedure or surgery
patients receive best treatment and care with an additional endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Not described Receives: Procedure: endoscopy |
| Standard care arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic recurrence of disease
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kamm, University of Melbourne
- Investigators
- Michael A Kamm, MBBS MD FRCP FRACP, Principal investigator, St Vincent's Hospital, Melbourne; University of MelbournePeter De Cruz, MBBS, FRACP, Principal investigator, St Vincent's Hospital, Melbourne; University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989560
- Sponsor's protocol ID
- HREC-A 077/09
- Acronym
- POCER
- Status last verified
- Jan 2014
- First submitted
- 2 Oct 2009
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34035441Wright 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.
PubMed 27076772Wright 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.
PubMed 25855073Wright 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.
PubMed 25620670De 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.
PubMed 25542620
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause
- ClinicalTrials.gov ID
- NCT00989560
- Acronym / sponsor ID
- POCER / HREC-A 077/09
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Procedure: endoscopy |
| Standard care arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of Crohn's and proven history of disease
- patient undergone surgical resection with creation of a primary anastomosis
Key exclusion criteria (5 listed)
- endoscopically inaccessible anastomosis by standard colonoscopy
- presence of an end stoma
- pregnancy
- suspected perforation of the gastrointestinal tract
- presence of certain unsuitable comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopypatients receive best treatment and care with an additional endoscopy | Procedure or surgery | Active arm |
Primary outcome
Endoscopic recurrence of disease
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Derived from this study: PubMed 34035441Teh 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.
- Derived from this study: PubMed 27076772Wright 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.
- Derived from this study: PubMed 25855073Wright 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.
- Derived from this study: PubMed 25620670Wright 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.
- Derived from this study: PubMed 25542620De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Kamm, MBBS MD FRCP FRACP principal investigator
St Vincent's Hospital, Melbourne; University of Melbourne
Peter De Cruz, MBBS, FRACP principal investigator
St Vincent's Hospital, Melbourne; University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing endoscopy in people with Crohn's Disease, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic recurrence of disease (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989560, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.