Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06265649 |
| Other study ID # |
NOM-ALCD |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Ospedali Riuniti Trieste |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 follow-up.
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.
