AppendicitisNCT01718275
Non-operative Management of Early Appendicitis in Children
An observational study of Appendicitis, run by Peter Minneci at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Appendicitis
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 22 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children treated a tertiary care Children's Hospital
Who may be able to join
- Age : 7-17 years
- Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, <1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT: hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon)
- White blood cell count (WBC) < 15,000
- C reactive protein (CRP) <4 (if obtained)
- Focal abdominal pain </= 36 hours prior to receiving antibiotics
Who cannot join
- English is not the primary language of either the child or parent/guardian
- Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (BMI ≥ 95th percentile for age and sex), severe developmental delay
- Positive urine pregnancy test
- Diffuse peritonitis
- Fecalith
- History of chronic intermittent abdominal pain
Show all 9Show fewer
- WBC >/= 15
- CRP>/= 4 (if obtained)
- Pain > 36 hours prior to first antibiotic dose 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
The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.
Read the detailed description
Non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. There have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children.
The primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. Recurrence is defined as need for appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.
This is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). There will be two cohorts; those who agree to receive non-operative management (Non-Operative Group) and those that permit us to track their standard treatment course (Surgery Group).
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Pediatrics, Children, Non-operative
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-operative Group | Patients and caregivers who agree to receive non-operative management with antibiotics alone | |
| Surgery Group | Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of Non-operative management
The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.
Measured: 1 year
Secondary outcomes (1)
Adverse Outcomes
The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.
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 posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completion22 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 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
- NCT01718275
- Sponsor's protocol ID
- IRB12-00406
- Status last verified
- Aug 2023
- First submitted
- 29 Oct 2012
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. doi: 10.1001/jamasurg.2015.4534.
PubMed 26676711Minneci 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 24951281
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-operative Management of Early Appendicitis in Children
- ClinicalTrials.gov ID
- NCT01718275
- Acronym / sponsor ID
- IRB12-00406
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Pediatrics, Children, Non-operative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Peter MinneciUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- 22 Aug 2023 (estimated)
- First posted
- 31 Oct 2012 (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.
The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.
Detailed description
Non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. There have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children.
The primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. Recurrence is defined as need for appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.
This is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). There will be two cohorts; those who agree to receive non-operative management (Non-Operative Group) and those that permit us to track their standard treatment course (Surgery Group).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-operative Group | – | –Patients and caregivers who agree to receive non-operative management with antibiotics alone |
| Surgery Group | – | –Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children treated a tertiary care Children's Hospital
Key inclusion criteria (5 listed)
- Age : 7-17 years
- Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, <1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT: hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon)
- White blood cell count (WBC) < 15,000
- C reactive protein (CRP) <4 (if obtained)
- Focal abdominal pain </= 36 hours prior to receiving antibiotics
Key exclusion criteria (9 listed)
- English is not the primary language of either the child or parent/guardian
- Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (BMI ≥ 95th percentile for age and sex), severe developmental delay
- Positive urine pregnancy test
- Diffuse peritonitis
- Fecalith
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
Failure of Non-operative management
Time frame: 1 year
The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.
1 secondary outcome
Adverse Outcomes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Results publication: PubMed 26676711Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. doi: 10.1001/jamasurg.2015.4534.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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?
An observational study of 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Aug 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 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?
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?
Failure of Non-operative management (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 NCT01718275, 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 24 Aug 2023.