Non-operative Management of Pediatric Appendicitis With an Appendicoltih
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ClinicalTrials.gov Identifier: NCT02189668 |
Recruitment Status :
Terminated
(High failure rate)
First Posted : July 14, 2014
Results First Posted : April 17, 2018
Last Update Posted : November 27, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Appendicitis | Drug: Antibiotics only (Zosyn then Augmentin) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Non-operative Management
Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic
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Drug: Antibiotics only (Zosyn then Augmentin)
Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic
Other Name: non operative management |
No Intervention: Surgery
Usual care with urgent appendectomy
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- 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
- Number of Participants With Complicated Appendicitis [ Time Frame: 1 year ]Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.

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Ages Eligible for Study: | 7 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age : 7-17 years
- Abdominal pain </= 48hours prior to receiving antibiotics
- White Blood Cell Count >5 but < 18
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US or CT confirmed early appendicitis plus:
- US: </=1.1 cm in diameter, presence of appendicolith
- CT: </= 1.1cm in diameter, presence of appendicolith
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189668
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Principal Investigator: | Peter C Minneci, MD | Nationwide Children's Hospital |
Other Publications:
Responsible Party: | Peter Minneci, Principal Investigator, Nationwide Children's Hospital |
ClinicalTrials.gov Identifier: | NCT02189668 |
Other Study ID Numbers: |
IRB14-00218 |
First Posted: | July 14, 2014 Key Record Dates |
Results First Posted: | April 17, 2018 |
Last Update Posted: | November 27, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Appendicitis Non-operative Children |
Appendicolith fecalith Pediatrics |
Appendicitis Intraabdominal Infections Infection Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Cecal Diseases |
Intestinal Diseases Anti-Bacterial Agents Amoxicillin-Potassium Clavulanate Combination Anti-Infective Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |