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.
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.
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.
recurrence after the first episode of diverticulitis
recurrence after the first episode of diverticulitis
Measured: 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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start31 May 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecurrenceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Ching Lien, PhD, Principal investigator, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Patients With Diverticulitis and Risk Factors for Recurrence: a Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT04500405
- Acronym / sponsor ID
- 202003113RINB
- Conditions
- Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 May 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- the patients who (a) received CT at other hospital and lost image; (b) lost the follow-up after index ED admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
recurrence after the first episode of diverticulitis
Time frame: 5 years
recurrence after the first episode of diverticulitis
1 secondary outcome
The diagnostic accuracy between the sonographic diagnosis and final diagnosis
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan-Ching Lien, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.