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CompletedNCT04500405Updated Sep 18, 2023

Outcomes of Patients With Diverticulitis and Risk Factors for Recurrence

An observational study in Recurrence, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.

Primary conditionnone(registry's first term: Recurrence)No conditionIs this wrong?Recurrence describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
20 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Recurrence

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03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

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

04

Who can participate

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

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.

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • the patients who (a) received CT at other hospital and lost image; (b) lost the follow-up after index ED admission.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. recurrence after the first episode of diverticulitis

    recurrence after the first episode of diverticulitis

    Time frame: 5 years

Secondary outcomes

  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

    Time frame: one month

07

Study locations

1 site
  • Lien
    Taipei, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2020 to primary completion in Aug 2023, 39 months.

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

Registered
Aug 2, 2020
First posted
Aug 5, 2020
StartActual
May 31, 2020
Primary completionActual
Aug 31, 2023
CompletionActual
Aug 31, 2023
Last update
Sep 18, 2023
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 Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04500405
Responsible party
Sponsor
First posted
Aug 5, 2020
Start date
May 31, 2020
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Sep 18, 2023

Study contacts

Wan-Ching Lien, PhD
principal investigator · National Taiwan University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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