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RecurrenceNCT04500405

Outcomes of Patients With Diverticulitis and Risk Factors for Recurrence

An observational study of Recurrence, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the Emergency Department (ED), patients with acute diverticulitis usually present with acute abdominal pain. Sometimes, or mostly, it is an exclusive diagnosis, meaning that the diagnosis would be made after other emergent and acute abdomens are excluded. The recurrent diverticulitis cost medical burden. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Recurrence
How many people
1,500 participants
Where
1 siteTaiwan
Study dates
31 May 2020to 31 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

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

Study population: The patients who (a) visited ED from Oct 2008 to Sep 2018; (b) were diagnosed as diverticulitis by computed tomography (CT); (c) were aged over 20.

Who may be able to join

  • the patients who (a) visited ED from Oct 2008 to Sep 2018; (b) were diagnosed as diverticulitis by computed tomography (CT); (c) were aged over 20.

Who cannot join

  • the patients who (a) received CT at other hospital and lost image; (b) lost the follow-up after index ED admission.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Lien

    Taipei

Other trials in Taiwan

About this study

Official title: Long-term Outcomes of Patients With Diverticulitis and Risk Factors for Recurrence: a Multi-center Cohort Study

In the Emergency Department (ED), patients with acute diverticulitis usually present with acute abdominal pain. Sometimes, or mostly, it is an exclusive diagnosis, meaning that the diagnosis would be made after other emergent and acute abdomens are excluded. The recurrent diverticulitis cost medical burden. The studies focusing on potential risk factors of recurrent diverticulitis, especially for those after an episode of acute diverticulitis, are limited.

Read the detailed description

Diverticular disease of the colon is common in industrial countries and has significant impact on patient health as well as health care cost. It is common in both Western countries and some Asian countries. For example, in the past, colonic diverticulosis was rare in Japan; with detection rates as low as approximately 2% in 1960. The detection rate increased to approximately 20% in the 1980s and 1990s. Studies have reported that increasing rates of diverticulosis are caused by westernization of the diet in Asian countries and are becoming a medical concern. Diverticular disease-associated hospital admissions have risen steeply in the recent past, which are not completely accounted for by the increasingly aging population of western countries. Approximately 130,000 hospitalizations occurring every year in the United States are attributable to diverticular disease. An analysis of the age-adjusted hospitalization rate of diverticulitis in the United States showed an increase from 62 per 100,000 in 1998 to 76 per 100,000 in 2005. These admission rates increased most in younger patients (< 45 years old) and have remained unchanged in patients older than 65 years. In spite of low mortality rate in patients with acute diverticulitis, moderate to severe comorbidities occur in specific patient group.

Painter and Burkitt hypothesized it in their article in 1960s and 1970s. They based their hypothesis on the observation that individuals in different geographic locations such as western industrialized countries versus those in developing countries were noted to have different rates of prevalence. They postulated that those in industrialized nations tended to eat processed food that was low in fiber compared with individuals in Africa and Asia, where the disease was previously unknown.

The USA Health Professional study showed a higher risk of diverticulitis in men with higher body mass index (BMI), waist-to-hip ratio and waist circumference [8]. Obesity also significantly increases costs associated with management of the disease and its complications [9]. The effect of obesity on the risk of recurrent diverticulitis is unknown.

In the Emergency Department (ED), patients with acute diverticulitis usually present with acute abdominal pain. Sometimes, or mostly, it is an exclusive diagnosis, meaning that the diagnosis would be made after other emergent and acute abdomens are excluded. The recurrent diverticulitis cost medical burden. The studies focusing on potential risk factors of recurrent diverticulitis, especially for those after an episode of acute diverticulitis, are limited.

This is a retrospective cohort study conduct from Oct 2008 to Sep 2018. The patients were recruited from National Taiwan University Hospital (NTUH), NTUH Hsin-Chu Branch (HCH), and NTUH Yun-Lin Branch.

Conditions
Recurrence
Medical subject headings
Recurrence

What is being measured

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

  1. recurrence after the first episode of diverticulitis

    recurrence after the first episode of diverticulitis

    Measured: 5 years

Secondary outcomes (1)
  1. The diagnostic accuracy between the sonographic diagnosis and final diagnosis

    The final diagnosis was referred to the diagnosis that two expert physicians reviewed the medical records

    Measured: one month

Timeline

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

  1. First posted5 Aug 2020
  2. Study start31 May 2020
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

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
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04500405
Sponsor's protocol ID
202003113RINB
Status last verified
Jan 2023
First submitted
2 Aug 2020
Last updated
18 Sep 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Recurrence, run by National Taiwan University Hospital at 1 site in Taiwan.

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: finished, as of the sponsor's last update on 18 Sep 2023. 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence after the first episode of diverticulitis (time frame: 5 years). 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 18 Sep 2023.

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