NCT06777043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
Last Updated

January 15, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

January 10, 2025

Last Update Submit

January 10, 2025

Conditions

IBD - Inflammatory Bowel Disease

Keywords

IBDCDIRA

Outcome Measures

Primary Outcomes (1)

  • Recurrence of disease

    Recurrence of disease

    within 2 years of the surgery

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32616463BACKGROUND

Related Links

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Fernando Rizzello, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

October 1, 2020

Primary Completion

December 31, 2020

Study Completion

April 1, 2021

Last Updated

January 15, 2025

Record last verified: 2024-12

Locations

IT(1)