UnknownNot Applicable

Multi-institutional Trial of Non-operative Management of Appendicitis

United States1,076 participantsStarted 2014-10-01

Plain-language summary

A successful non-operative management strategy for early appendicitis will decrease the number of children requiring surgery and may improve the quality of care related to the treatment of appendicitis. To account for the child-family perspective and treatment preferences, the investigators will perform a study in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten U.S. hospitals. This study will determine the effectiveness of non-operative management of early appendicitis with antibiotics alone in children and compare differences in morbidity, disability, quality of life, satisfaction, and cost between families choosing surgery or non-operative management.

Who can participate

Age range

8 Years – 17 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English and non-English speaking patients * Age : 8-17 years * US or CT confirmed early appendicitis with US showing hyperemia, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, ≤ 1.1 cm in diameter, no abscess, no fecalith, no phlegmon * White Blood Cell count \> 5,000/µL and ≤ 18,000/µL * Abdominal pain ≤ 48hours prior to receiving antibiotics Exclusion Criteria: * History of chronic intermittent abdominal pain * Pain \> 48 hours prior to first antibiotic dose * Diffuse peritonitis * Positive urine pregnancy test * White Blood Cell ≤ 5,000/µL or ≥ 18,000/µL * Presence of a fecalith on imaging * Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon * Communication difficulties (e.g. severe developmental delay)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Success rate

Timeframe: 1 year

Disability Days

Timeframe: 1 year

Trial details

NCT IDNCT02271932

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-11-01

View on ClinicalTrials.gov More Appendicitis trials