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RecruitingNCT06265649Updated Apr 4, 2025

Comparison of NOM for ACLD Between Medical and Surgical Ward

An observational study in Diverticulitis, Colon Disease and Acute Diverticulitis, sponsored by Ospedali Riuniti Trieste. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Ospedali Riuniti Trieste · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
175
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Acute diverticulitis is one of the most common gastrointestinal disorders, with an estimated lifetime risk ranging from 10 to 25%. Notably this condition predominantly affects the left side of the colon (Acute Left Colon Diverticulitis - ALCD). Over the years, advancements in radiological imaging techniques have led to the modification of the original Hinchey classification, and in 2015 the World Society of Emergency Surgery (WSES) introduced a novel classification based on computer tomography (CT) findings. The prevalence of ALCD is on the rise in Western countries, with a marked increase of 132% observed between 1980 and 2007, especially among individuals aged 40 to 49 years. This trend is also evident in Italy, where there was a substantial rise in admission rates between 2008 and 2015, increasing from 8.8 to 11.8 cases per 100,000 inhabitants, primarily among those under 60 years old. Consequently, this surge in ALCD cases has led to elevated healthcare costs, particularly when surgical intervention is not required. Notably, only around 5% of patients with ALCD experience complicated episodes, indicating that uncomplicated ALCD (U-ACLD) is more common than complicated ACLD (C-ALCD). However, current clinical practice still demonstrates high admission rates for both U-ACLD and C-ALCD, particularly among the elderly with comorbidities. Given that surgery is not always warranted, patients are often admitted to non-surgical departments, although no specific guidelines exist to determine which facility is the most suitable.

There remains a dearth of knowledge regarding the comparative management of ALCD between surgical and non-surgical wards in cases of non-operative management (NOM). Some studies demonstrated similar outcomes among patients admitted to both surgical and non-surgical units.

In this context, the primary objective of the current study is to compare ALCD patients admitted for NOM to the surgical ward with those admitted to a non-surgical ward. Specifically, the study aims to assess clinical outcomes (such as gastrointestinal disorders and the restoration of a regular diet), hospitalization length (Length of Stay - LOS), and post-admission follow-up.

The following data were collected: age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, previous ALCD episodes (requiring or not requiring hospitalization), C-reactive protein (CRP) levels on admission, type of management (i.e. no treatment, antimicrobial therapy, percutaneous drainage), LOS, post-discharge colonoscopy, follow-up visits, and ALCD recurrence. Follow-up data were retrieved from the electronic records covering two years after the episodes. ALCD was classified using the Hinchey classification modified by Wasvary et al. based on CT findings on admission. According to the admission department, the study population was divided into two groups: a surgical group (SG) and a non-surgical group (NSG). The ward of hospitalization was decided by the emergency doctor according to bed availability: if there were beds in the surgical ward, patients were preferably hospitalized there, otherwise, a non-surgical environment was chosen. The non-surgical wards were mainly the two wards of Internal Medicine. Criteria considered for discharge include resolution of fever, pain reduction with no need for constant use of painkillers, free oral feeding, normalization of white blood cell count, and more than a 50% decrease in the serum levels of CRP. Recurrence was defined as a new ALCD episode confirmed by a CT scan not earlier than 2 months after the first episode.

To compare ALCD management in non-surgical and surgical environments, SG subjects were propensity-score matched (PSM) to NSG subjects on ALCD grade according to the classification modified by Wasvary et al., to reduce the bias related to ALCD grade.

This decision was made also to study which factors of patients' baseline characteristics (age, sex, BMI, ASA score, CRP levels) mainly differ between the two Groups. The Shapiro-Wilk test was used to analyze quantitative variables. Nominal variables are expressed as numbers and percentages, non-normal quantitative variables as median and range, and normal variables as mean and standard deviation (SD). Chi-squared and Fisher's exact test were used to compare nominal variables, whereas the Mann-Whitney U test was used for non-normal quantitative variables and the T-student test for normal quantitative variables. A multivariate logistic regression analysis was conducted to evaluate if age, sex, ASA score, and hospitalization ward were independent predictors in readmission, the lack of follow-up, and receiving a colonoscopy. Data are represented in odds ratio (ORs) and Confidence Interval (CI) of 95%. P values \< 0.05 were considered statistically significant.

02

Conditions studied

  • Diverticulitis
  • Colon Disease
  • Acute Diverticulitis

Keywords

  • diverticulitis
  • non-operative management
03

In context

Diverticulitis

125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.

This study's planned enrollment of 175 is below the median of 275 across 59 observational studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Ospedali Riuniti Trieste is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients affected by ALCD

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • immediate indication for surgery (i.e. patients with Hinchey III or IV ALCD or septic patients with Hinchey II)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
175 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNOM

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

06

What researchers measure

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)

    Time frame: one month after admission

Secondary outcomes

  1. Follow-up and recurrences

    Comparing patients with ACLD admitted for NOM to the surgical ward with those admitted to a non-surgical ward in terms of follow-up and ACLD recurrences

    Time frame: two years after the admission

07

Study locations

1 of 1 sites recruiting
  • Manuela Mastronardi
    Trieste, TS 34149, Italy
    Recruiting
    • Manuela Mastronardi, MD · Contactmanuela.mastronardi@gmail.com · 0403994152
    • Alan Biloslavo, MD · Principal investigator
    • Margherita Sandano, MD · Sub investigator
    • Paola Germani, MD · Sub investigator
    • Stefano Fracon, MD · Sub investigator
    • Davide Cosola, MD · Sub investigator
    • Selene Bogoni, MD · Sub investigator
    • Nicolò de Manzini, MD · Principal investigator
    • Marina Troian, MD · Sub investigator
    • Nicola Artusi, MD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2025, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2024
First posted
Feb 20, 2024
StartActual
Jan 1, 2024
Primary completionEst.
Dec 2025
CompletionEst.
Jan 2026
Last update
Apr 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06265649
Lead sponsor
Ospedali Riuniti Trieste
Responsible party
Manuela Mastronardi (Principal Investigator, Ospedali Riuniti Trieste) — Principal investigator
First posted
Feb 20, 2024
Start date
Jan 1, 2024
Primary completion
Dec 2025 (estimated)
Completion
Jan 2026 (estimated)
Last update
Apr 4, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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