IBD - Inflammatory Bowel DiseaseNCT06777043
Long-term Remission After Ileorectal Anastomosis in Crohn's Disease.
An observational study of IBD - Inflammatory Bowel Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Single-center, retrospective, observational study. The medical records of patients who underwent colectomy and ileorectal anastomosis (IRA) for refractory Crohn's colitis between 1996 and 2016 were reviewed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD - Inflammatory Bowel Disease
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 1 Apr 2021
- Phase
- Observational
- 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
Study population: patients with Crohn's disease who underwent colectomy and ileorectal anastomosis between 1996 and 2016, in a single IBD tertiary center
Who may be able to join
- patients with Crohn's colitis who underwent colectomy and ileorectal anastomosis
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Single-center, retrospective, observational study. The medical records of patients who underwent colectomy and ileorectal anastomosis (IRA) for refractory Crohn's colitis between 1996 and 2016 were reviewed.
Read the detailed description
Several studies show that, although the type of disease changes in a statistically significant way after 5 years from diagnosis, overall, a follow-up of more than 10 years indicates that the disease remains unchanged in about 85% of patients. Studies show that up to 70% of patients with Crohn's disease (CD) undergo surgery at least once in their lifetime. In colon Crohn's disease, the cumulative risk of surgery 10 years after diagnosis is lower compared to ileal Crohn's disease. For patients with extensive colitis who do not respond to medical therapy, total colectomy with ileorectal anastomosis (IRA) is a safe and effective approach. Several studies in the literature have retrospectively evaluated the recurrence rate after colectomy and IRA in Crohn's disease-related colitis, showing reasonable recurrence rates. Furthermore, several studies have highlighted that rectal involvement and the presence of perianal disease may be predictive factors for recurrence in Crohn's colitis treated with colectomy and ileorectal anastomosis (IRA). Ileal involvement in colectomy in patients with Crohn's colitis appears to be associated with a higher risk of recurrence in the small intestine and failure of the IRA. Our study is based on the hypothesis that, in patients with extensive and refractory Crohn's colitis but without rectal involvement or perianal disease, colectomy and IRA could instead drastically reduce the recurrence rate.
- Conditions
- IBD - Inflammatory Bowel Disease
- Keywords
- IBD, CD, IRA
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with isolated colonic Crohn's disease | The first group had isolated colonic Crohn's disease without rectal involvement and perianal disease | |
| Patients with rectal and/or ileal Crohn's disease | the second group included patients who had rectal and/or ileal involvement, with or without perianal disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of disease
Recurrence of disease
Measured: within 2 years of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBD - Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Rizzello, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777043
- Sponsor's protocol ID
- IRA
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salice M, Rizzello F, Sgambato D, Calabrese C, Manguso F, Laureti S, Rottoli M, Poggioli G, Gionchetti P. Long term remission after ileorectal anastomosis in Crohn's colitis. Dig Liver Dis. 2021 May;53(5):592-597. doi: 10.1016/j.dld.2020.06.021. Epub 2020 Jun 29.
PubMed 32616463
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Remission After Ileorectal Anastomosis in Crohn's Disease.
- ClinicalTrials.gov ID
- NCT06777043
- Acronym / sponsor ID
- IRA
- Conditions
- IBD - Inflammatory Bowel Disease
- Keywords
- IBD, CD, IRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 15 Jan 2025 (actual)
- 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.
Single-center, retrospective, observational study. The medical records of patients who underwent colectomy and ileorectal anastomosis (IRA) for refractory Crohn's colitis between 1996 and 2016 were reviewed.
Detailed description
Several studies show that, although the type of disease changes in a statistically significant way after 5 years from diagnosis, overall, a follow-up of more than 10 years indicates that the disease remains unchanged in about 85% of patients. Studies show that up to 70% of patients with Crohn's disease (CD) undergo surgery at least once in their lifetime. In colon Crohn's disease, the cumulative risk of surgery 10 years after diagnosis is lower compared to ileal Crohn's disease. For patients with extensive colitis who do not respond to medical therapy, total colectomy with ileorectal anastomosis (IRA) is a safe and effective approach. Several studies in the literature have retrospectively evaluated the recurrence rate after colectomy and IRA in Crohn's disease-related colitis, showing reasonable recurrence rates. Furthermore, several studies have highlighted that rectal involvement and the presence of perianal disease may be predictive factors for recurrence in Crohn's colitis treated with colectomy and ileorectal anastomosis (IRA). Ileal involvement in colectomy in patients with Crohn's colitis appears to be associated with a higher risk of recurrence in the small intestine and failure of the IRA. Our study is based on the hypothesis that, in patients with extensive and refractory Crohn's colitis but without rectal involvement or perianal disease, colectomy and IRA could instead drastically reduce the recurrence rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with isolated colonic Crohn's disease | – | –The first group had isolated colonic Crohn's disease without rectal involvement and perianal disease |
| Patients with rectal and/or ileal Crohn's disease | – | –the second group included patients who had rectal and/or ileal involvement, with or without perianal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Crohn's disease who underwent colectomy and ileorectal anastomosis between 1996 and 2016, in a single IBD tertiary center
Key inclusion criteria (1 listed)
- patients with Crohn's colitis who underwent colectomy and ileorectal anastomosis
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of disease
Time frame: within 2 years of the surgery
Recurrence of disease
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 15 Jan 2025.
- Background: PubMed 32616463Salice M, Rizzello F, Sgambato D, Calabrese C, Manguso F, Laureti S, Rottoli M, Poggioli G, Gionchetti P. Long term remission after ileorectal anastomosis in Crohn's colitis. Dig Liver Dis. 2021 May;53(5):592-597. doi: 10.1016/j.dld.2020.06.021. Epub 2020 Jun 29.
- "Long term remission after ileorectal anastomosis in Crohn's colitis"Link provided by the sponsor.
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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.
Fernando Rizzello, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD - Inflammatory Bowel Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 inclusion and 1 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 15 Jan 2025. 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 Italy. 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.
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?
Recurrence of disease (time frame: within 2 years of the surgery). 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 NCT06777043, which also lists 1 linked publication.
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 15 Jan 2025.