NCT06265649

Brief Summary

In Europe, patients with acute left colon diverticulitis (ALCD) are usually admitted to surgical wards even when only medical treatment is required. The study compares ALCD non-operative management (NOM) between surgical and non-surgical environments regarding clinical outcomes, hospitalization length(LOS), and follow-up.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

January 6, 2024

Last Update Submit

April 2, 2025

Conditions

DiverticulitisColon DiseaseAcute Diverticulitis

Keywords

diverticulitisnon-operative management

Outcome Measures

Primary Outcomes (1)

  • Hospitalization length

    Comparing patients with ACLD admitted for NOM to the surgical ward with those admitted to a non-surgical ward in terms of length of stay (LOS)

    one month after admission

Secondary Outcomes (1)

  • Follow-up and recurrences

    two years after the admission

Study Arms (2)

Surgical Group (SG)

Patients with ALCD undergoing NOM admitted to the surgical ward

Other: NOM

Non-Surgical Group (NSG)

Patients with ALCD undergoing NOM admitted to the medical ward

Other: NOM

Interventions

NOMOTHER

Non-operative management (NOM) for ALCD consists of lab test monitoring, fluid therapy, antibiotic therapy, abscess drainage if \>4cm, restoring a regular diet

Non-Surgical Group (NSG)Surgical Group (SG)

Eligibility Criteria

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

Patients affected by ALCD

You may qualify if:

  • patients affected by ALCD using a contrast-enhanced CT scan at admission undergoing NOM

You may not qualify if:

  • immediate indication for surgery (i.e. patients with Hinchey III or IV ALCD or septic patients with Hinchey II)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuela Mastronardi

Trieste, TS, 34149, Italy

RECRUITING

MeSH Terms

Conditions

DiverticulitisColonic Diseases

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2024

First Posted

February 20, 2024

Study Start

January 1, 2024

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations

IT(1)