AppendicitisNCT02189668
Non-operative Management of Pediatric Appendicitis With an Appendicoltih
A study testing Antibiotics only (Zosyn then Augmentin) in people with Appendicitis, run by Peter Minneci at 1 site in United States.
Trial summary
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Antibiotics only (Zosyn then Augmentin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age : 7-17 years
- Abdominal pain </= 48hours prior to receiving antibiotics
- White Blood Cell Count >5 but < 18
- US or CT confirmed early appendicitis plus:
- US: </=1.1 cm in diameter, presence of appendicolith
- CT: </= 1.1cm in diameter, presence of appendicolith
Who cannot join
- Positive urine pregnancy test
- Pain > 48 hours prior to first antibiotic dose
- Diffuse peritonitis
- History of chronic intermittent abdominal pain
- White Blood Cell count ≤ 5 or ≥ 18
- Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
Read the detailed description
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.
- Conditions
- Appendicitis
- Being tested
- Antibiotics only (Zosyn then Augmentin)
- Keywords
- Appendicitis, Non-operative, Children, Appendicolith, fecalith, Pediatrics
- Medical subject headings
- Appendicitis, Fecal Impaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics only (Zosyn then Augmentin)Drug
Also called non operative management
Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic
| Study group | Role | What they receive |
|---|---|---|
| Non-operative Management | Experimental | Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Receives: Drug: Antibiotics only (Zosyn then Augmentin) |
| Surgery | No intervention | Usual care with urgent appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Did Not Have an Appendectomy
Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
Measured: 1 year
Secondary outcomes (1)
Number of Participants With Complicated Appendicitis
Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: High failure rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Minneci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Minneci, Nationwide Children's Hospital
- Investigators
- Peter C Minneci, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189668
- Sponsor's protocol ID
- IRB14-00218
- Status last verified
- Oct 2018
- First submitted
- 3 Jul 2014
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031. Epub 2014 Apr 13.
PubMed 24951281Mahida JB, Lodwick DL, Nacion KM, Sulkowski JP, Leonhart KL, Cooper JN, Ambeba EJ, Deans KJ, Minneci PC. High failure rate of nonoperative management of acute appendicitis with an appendicolith in children. J Pediatr Surg. 2016 Jun;51(6):908-11. doi: 10.1016/j.jpedsurg.2016.02.056. Epub 2016 Mar 2.
PubMed 27018085
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children
- ClinicalTrials.gov ID
- NCT02189668
- Acronym / sponsor ID
- IRB14-00218
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Non-operative, Children, Appendicolith, fecalith, Pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High failure rate
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Peter MinneciUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
Detailed description
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-operative Management | Experimental | Drug: Antibiotics only (Zosyn then Augmentin)Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic |
| Surgery | No intervention | –Usual care with urgent appendectomy |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age : 7-17 years
- Abdominal pain </= 48hours prior to receiving antibiotics
- White Blood Cell Count >5 but < 18
- US or CT confirmed early appendicitis plus:
Key exclusion criteria (6 listed)
- Positive urine pregnancy test
- Pain > 48 hours prior to first antibiotic dose
- Diffuse peritonitis
- History of chronic intermittent abdominal pain
- White Blood Cell count ≤ 5 or ≥ 18
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 |
|---|---|---|
| Antibiotics only (Zosyn then Augmentin)Also: non operative managementIntravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic | Drug | Non-operative Management |
Primary outcome
Number of Participants That Did Not Have an Appendectomy
Time frame: 1 year
Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
1 secondary outcome
Number of Participants With Complicated Appendicitis
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24951281Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031. Epub 2014 Apr 13.
- Results publication: PubMed 27018085Mahida JB, Lodwick DL, Nacion KM, Sulkowski JP, Leonhart KL, Cooper JN, Ambeba EJ, Deans KJ, Minneci PC. High failure rate of nonoperative management of acute appendicitis with an appendicolith in children. J Pediatr Surg. 2016 Jun;51(6):908-11. doi: 10.1016/j.jpedsurg.2016.02.056. Epub 2016 Mar 2.
- Individual participant dataSharing planned: No
Related trials for Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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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.
Peter C Minneci, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotics only (Zosyn then Augmentin) in people with Appendicitis, run by Peter Minneci 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 6 inclusion and 6 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 27 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Did Not Have an Appendectomy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189668, which also lists 2 linked publications.
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 27 Nov 2018.