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DiverticulitisNCT06265649

Comparison of NOM for ACLD Between Medical and Surgical Ward

An observational study of Diverticulitis and Colon Disease, run by Ospedali Riuniti Trieste at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NOM
How many people
175 participants
Where
1 siteItaly
Study dates
1 Jan 2024to Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients affected by ALCD

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • Manuela Mastronardi

    Trieste, TS, 34149

    Manuela Mastronardi, MD, 0403994152 ext. 0039, manuela.mastronardi@gmail.com

    Alan Biloslavo, MD

    Recruiting

Other trials in Italy

About this study

Official title: Acute Left Colon Diverticulitis: is it Still a Surgical Disease When Only Medical Treatment is Required? A Retrospective Study Based on Propensity Score Matching

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.

Being tested
NOM
Keywords
diverticulitis, non-operative management
Medical subject headings
Diverticulitis, Colonic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOMOther

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

Study groups in NCT06265649
Study groupRoleWhat they receive
Surgical Group (SG)Patients with ALCD undergoing NOM admitted to the surgical ward
Receives: Other: NOM
Non-Surgical Group (NSG)Patients with ALCD undergoing NOM admitted to the medical ward
Receives: Other: NOM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: one month after admission

Secondary outcomes (1)
  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

    Measured: two years after the admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start1 Jan 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06265649
Sponsor's protocol ID
NOM-ALCD
Status last verified
Apr 2025
First submitted
6 Jan 2024
Last updated
4 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diverticulitis and Colon Disease, run by Ospedali Riuniti Trieste at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization length (time frame: one month after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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