Perforated AppendicitisNCT00540189
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
A study testing Initial appendectomy and Interval appendectomy in people with Perforated Appendicitis, run by University of Michigan at 1 site in United States.
Trial summary
To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- Initial appendectomy and Interval appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2010
- Phase
- Interventional
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-17 with a diagnosis of perforated appendicitis
Who cannot join
- Age <2 and >18
- Pregnancy
- Immunocompromise
Trial locations and contacts
1 site in 1 country.
About this study
To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.
- Conditions
- Perforated Appendicitis
- Being tested
- Initial appendectomy, Interval appendectomy
- Keywords
- appendicitis, perforated, children
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial appendectomyProcedure or surgery
Interval appendectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Initial appendectomy | Other | children with complicated appendicitis will undergo initial appendectomy Receives: Procedure: Initial appendectomy |
| Interval appendectomy | Other | children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy Receives: Procedure: Interval appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost effectiveness
Measured: 3 months post entry into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Unable to adequatly recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven W. Bruch, University of Michigan
- Investigators
- Steven W Bruch, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540189
- Sponsor's protocol ID
- HUM00007791
- Status last verified
- Dec 2016
- First submitted
- 4 Oct 2007
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
- ClinicalTrials.gov ID
- NCT00540189
- Acronym / sponsor ID
- HUM00007791
- Conditions
- Perforated Appendicitis
- Keywords
- appendicitis, perforated, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to adequatly recruit
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Oct 2007 (estimated)
- 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.
To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial appendectomy | Other | Procedure: Initial appendectomychildren with complicated appendicitis will undergo initial appendectomy |
| Interval appendectomy | Other | Procedure: Interval appendectomychildren with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 2-17 with a diagnosis of perforated appendicitis
Key exclusion criteria (3 listed)
- Age <2 and >18
- Pregnancy
- Immunocompromise
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 |
|---|---|---|
| Initial appendectomy | Procedure or surgery | Initial appendectomy |
| Interval appendectomy | Procedure or surgery | Interval appendectomy |
Primary outcome
cost effectiveness
Time frame: 3 months post entry into the study
Results and safety
The study was stopped early (reason given: Unable to adequatly recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
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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.
Steven W Bruch, MD, MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial appendectomy and Interval appendectomy in people with Perforated Appendicitis, run by University of Michigan 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 1 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: stopped early, as of the sponsor's last update on 19 Dec 2016. 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 was stopped early (reason given: Unable to adequatly recruit). Results are not available in the source record.
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?
cost effectiveness (time frame: 3 months post entry into the study). 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 19 Dec 2016.