Non-operative Management of Pediatric Appendicitis With an Appendicoltih
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| ClinicalTrials.gov Identifier: NCT02189668 |
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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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Sponsor:
Peter Minneci
Information provided by (Responsible Party):
Peter Minneci, Nationwide Children's Hospital
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Appendicitis | Drug: Antibiotics only (Zosyn then Augmentin) | Not Applicable |
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 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
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No Intervention: Surgery
Usual care with urgent appendectomy
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Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Number of Participants With Complicated Appendicitis [ Time Frame: 1 year ]Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 7 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Locations
| United States, Ohio | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
Sponsors and Collaborators
Peter Minneci
Investigators
| Principal Investigator: | Peter C Minneci, MD | Nationwide Children's Hospital |
Publications of Results:
Other Publications:
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 |
Keywords provided by Peter Minneci, Nationwide Children's Hospital:
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Appendicitis Non-operative Children |
Appendicolith fecalith Pediatrics |
Additional relevant MeSH terms:
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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 |