Long-term Remission After Ileorectal Anastomosis in Crohn's Disease.

January 10, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with Crohn's disease who underwent colectomy and ileorectal anastomosis between 1996 and 2016, in a single IBD tertiary center

Description

Inclusion Criteria:

  • patients with Crohn's colitis who underwent colectomy and ileorectal anastomosis

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of disease
Time Frame: within 2 years of the surgery
Recurrence of disease
within 2 years of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Fernando Rizzello, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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