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

NCT ID: NCT06777043

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-04-01

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with isolated colonic Crohn's disease

The first group had isolated colonic Crohn's disease without rectal involvement and perianal disease

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Rizzello, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 32616463 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/32616463/

"Long term remission after ileorectal anastomosis in Crohn's colitis"

Other Identifiers

IRA

Identifier Type: -

Identifier Source: org_study_id