Acute AppendicitisNCT04968782
Appendicitis Choice of Treatment Study
An observational study of Acute Appendicitis, run by University of Washington at 1 site in United States.
Trial summary
A longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. Survey evaluates patients experience with decision making and the types of decision support they receive. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Patients with acute appendicitis
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 16 Feb 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to the emergency department with acute appendicitis who are considered to be candidates for operative or nonoperative management by the treating clinical team. Patients can ultimately have undergone either treatment.
Who may be able to join
- English Speaking
- Diagnosed with acute appendicitis
- Considered by the treating clinical team to be eligible for treatment with surgery or with non operative treatment (antibiotics)
- Access to an internet connected device capable of taking the survey
Who cannot join
- Patients who do not make their own medical decisions
- Patients who are not felt to be candidates for a decision between operative and nonoperative treatment by the treating clinical team
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
A longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. Survey evaluates patients experience with decision making and the types of decision support they receive.
- Conditions
- Acute Appendicitis
- Being tested
- Patients with acute appendicitis
- Keywords
- Decision Making, Decisional Conflict
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with acute appendicitisOther
No intervention, single survey
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute appendicitis | Not described Receives: Other: Patients with acute appendicitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Validated evaluation of decision making
Measured: Time of survey (2 days-2 weeks after treatment for acute appendicitis)
Secondary outcomes (1)
Preparation for decision making
Validated measure for patient subject preparedness to make a treatment decision
Measured: Time of survey (2 days-2 weeks after treatment for acute appendicitis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start12 Jul 2021
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David R Flum, MD, MPH, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968782
- Sponsor's protocol ID
- STUDY00013390
- Status last verified
- Mar 2022
- First submitted
- 8 Jul 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appendicitis Choice of Treatment Study
- ClinicalTrials.gov ID
- NCT04968782
- Acronym / sponsor ID
- STUDY00013390
- Conditions
- Acute Appendicitis
- Keywords
- Decision Making, Decisional Conflict
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 20 Jul 2021 (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.
A longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. Survey evaluates patients experience with decision making and the types of decision support they receive.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute appendicitis | – | Other: Patients with acute appendicitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department with acute appendicitis who are considered to be candidates for operative or nonoperative management by the treating clinical team. Patients can ultimately have undergone either treatment.
Key inclusion criteria (4 listed)
- English Speaking
- Diagnosed with acute appendicitis
- Considered by the treating clinical team to be eligible for treatment with surgery or with non operative treatment (antibiotics)
- Access to an internet connected device capable of taking the survey
Key exclusion criteria (3 listed)
- Patients who do not make their own medical decisions
- Patients who are not felt to be candidates for a decision between operative and nonoperative treatment by the treating clinical team
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with acute appendicitisNo intervention, single survey | Other | Patients with acute appendicitis |
Primary outcome
Decisional conflict
Time frame: Time of survey (2 days-2 weeks after treatment for acute appendicitis)
Validated evaluation of decision making
1 secondary outcome
Preparation for decision making
Time frame: Time of survey (2 days-2 weeks after treatment for acute appendicitis)
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 23 Mar 2022.
- Decisional Conflict ScaleLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
David R Flum, MD, MPH study director
University of Washington
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 Acute Appendicitis, run by University of Washington at 1 site in United States.
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 4 inclusion and 3 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 23 Mar 2022. 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 United States. 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?
Decisional conflict (time frame: Time of survey (2 days-2 weeks after treatment for acute appendicitis)). 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 23 Mar 2022.