- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02447224
Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis
April 8, 2018 updated by: David A. Talan, Olive View-UCLA Education & Research Institute
A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.
Study Overview
Status
Completed
Conditions
Detailed Description
This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Sylmar, California, United States, 91342
- Olive View-UCLA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult or child ages ≥5 years;
- Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;
- Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and
- Negative pregnancy test for subjects who are women of childbearing potential.
Exclusion Criteria:
- instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antibiotics
Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.
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Active Comparator: Appendectomy
Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Complications
Time Frame: 30 days
|
The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used.
In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.
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30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrent appendicitis
Time Frame: 30 days
|
30 days
|
QOL outcomes
Time Frame: 30 days
|
30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
May 14, 2015
First Submitted That Met QC Criteria
May 15, 2015
First Posted (Estimate)
May 18, 2015
Study Record Updates
Last Update Posted (Actual)
April 10, 2018
Last Update Submitted That Met QC Criteria
April 8, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21DK102048 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Uncomplicated Appendicitis
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Turku University HospitalOulu University Hospital; Kuopio University Hospital; Seinajoki Central Hospital and other collaboratorsNot yet recruitingUncomplicated Acute AppendicitisFinland
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Hospital Universitario Virgen de la ArrixacaUnknownUncomplicated Acute AppendicitisSpain
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North Estonia Medical CentreTartu University HospitalRecruitingAcute Appendicitis | Appendicitis Acute | Appendicitis Perforated | Acute Appendicitis With Rupture | Appendicitis; Perforation | Acute Appendicitis Without Peritonitis | Acute Appendicitis With Appendix AbscessEstonia
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Pirogov Russian National Research Medical UniversityCompletedAcute Appendicitis | Acute Appendicitis With Rupture | Acute Appendicitis Without Peritonitis | Acute Appendicitis With PeritonitisRussian Federation
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HJ23Hospital Universitari Joan XXIII de Tarragona.Not yet recruitingAcute Appendicitis | Appendicitis Perforated | Appendicitis Suppurative
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Centre Hospitalier Universitaire, AmiensRecruiting
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Tanta UniversityCompletedDiagnosis of Acute Appendicitis in ChildrenEgypt
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Nigde Omer Halisdemir UniversityCompletedAcute Appendicitis | Acute Appendicitis With RuptureTurkey
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A.O. Ospedale Papa Giovanni XXIIIUnknownAcute Appendicitis Without PeritonitisItaly
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Kahramanmaras Sutcu Imam UniversityCompletedMedical Emergencies | Acute Appendicitis Without PeritonitisTurkey
Clinical Trials on Appendectomy
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Centre Hospitalier Universitaire de NiceRecruiting
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Hanoi Medical UniversityCompleted
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Far Eastern Memorial HospitalUnknown
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Medical Park Gaziantep HospitalMuğla Sıtkı Koçman University; Bahçeşehir UniversityCompletedAcute Appendicitis
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Oregon Health and Science UniversityChildren's Hospital Los AngelesCompleted
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Children's Mercy Hospital Kansas CityCompletedAppendicitisUnited States
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Maltepe UniversityCompleted
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Hospital Authority, Hong KongUnknown