Clinical trial NCT03795194
Conditions: Complicated Appendicitis Perforated Appendicitis
Sponsor: Phoenix Children's Hospital
Start date: 2019-05-01; Completion date: 2021-12-15
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized study of patients 2-17 years old who are diagnosed with perforated appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in clinical outcomes.

Detailed description:
The central aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in primary and secondary clinical outcomes. Specifically, this research aims to determine whether the readmission rate and length of stay for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic abscess that is treated with percutaneous drainage and are treated with a 8-day oral antibiotic regimen at discharge is significantly different from those treated with a fixed 4-day regimen at discharge.

This study includes patients ages 2-17 years old who present with perforated appendicitis-as diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen-and who develop an abscess after laparoscopy that is treated with percutaneous drainage.

All post-laparoscopic abscess patients will receive the standard of care for antibiotic therapy at Phoenix Children's Hospital-IV ceftriaxone/metronidazole-until afebrile and tolerating food. All patients will be treated with the PCH standard of care and receive in-patient treatment for abscess until afebrile.

At discharge, study patients will be randomly assigned to either an 8-day ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients who are allergic to ampicillin will be excluded from the study. Patients will be followed thirty days post discharge to assess clinical outcomes.

Arms: arm 1: 8-day course of ampicillin clavulanate antibiotic arm 2: 4--day course of ampicillin clavulanate antibiotic
Interventions: intervention 1: ampicillin/clavulanate
Intervention descriptions: intervention 1: FDA-approved antibiotic

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
PROTOCOL 
PROTOCOL TITLE 
A prospective randomized trial of antibiotic duration in post-
appendectomy abscess 
PROTOCOL NUMBER 
17-055 
STUDY DESIGN (PHASE) 
Prospective randomized 
PROTOCOL VERSION 
Version 5 Dated September 25, 2019 
NCT NUMBER 
NCT03795194 
 
 
SPONSOR 
Craig Egan, MD 
Phoenix Children’s Hospital 
1919 East Thomas Road 
Phoenix, Arizona 85016 
 
PRINCIPAL INVESTIGATOR 
Craig Egan, MD 
 
 
 
 
 
 
 
 
 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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V5 9/25/2019 
Absract 
Appendicitis is a very common surgical problem in children. Although the rates of post-
appendectomy abscess in simple appendicitis are less than 1%, the rates of post-
appendectomy abscess in complicated appendicitis are not well-described.5-8 Complicated 
appendicitis includes patients who present with a visible perforation and/or feces in the 
abdomen, a primary abscess, phlegmon, gangrene, or all of the above.2-4 Research 
suggests that neither the type of the antibiotic therapy nor duration of treatment has a 
significant impact on reducing the risk of post-operative abscess for patients who present 
with any form of complicated appendicitis.7 However, the lack of an evidence-based 
definition of perforated appendicitis has undermined the reliability of most research 
results because the study populations may have included non-complicated patients. In this 
study, we propose to assess the equivalence of an 8-day fixed course and a fixed 4-day 
course of antibiotics at drainage for perforated patients who develop a post-surgical 
abscess. We are proposing to study 342 pediatric patients (includes 10% oversampled) 
ages 2 to 17 years at institutions in the Western Surgical Pediatric Research Consortium 
(WSPRC) who are diagnosed with perforated appendicitis, treated laparoscopically, and 
form an abscess post-laparoscopy. We hypothesize that the 8-day course of antibiotics is 
equivalent to the 4-day course on the primary clinical outcome (i.e., readmission rate) and 
secondary outcomes: length of stay (LOS) upon readmission; rate of abscess from 
drainage until 30 days after discharge, and wound infection from drainage until 30 days 
of discharge. This research will provide an ongoing contribution to the clinical 
management of complicated pediatric appendicitis and antibiotic stewardship. 
 
A. Introduction/Background 
 
In the United States, appendicitis is among the top five diagnoses for pediatric hospital 
admissions and accounts for 11.3 pediatric patients per 10,000 of the general population.1 
Generally, complicated appendicitis is associated with a higher risk of developing intra-
abdominal abscess after appendectomy as compared to non-complicated appendicitis, 
where the rate of post-operative abscess is under 1%.1 Approximately 20 to 35% of all 
children who present with appendicitis present with complicated appendicitis as defined 
by perforation, phlegmon, or abscess.2–4 However, the reported risk of developing 
abscess after appendectomy in this patient group is less well described because 
researchers have not used one clear, consistent, evidenced-based definition of perforated 
appendicitis.14, 16 
 
There is a growing body of research regarding the regimen of antibiotic treatment in adult 
patients with confirmed complicated appendicitis. Antibiotic treatments vary by hospital, 
clinical parameters, and patient condition.12 A recent randomized, prospective pilot study 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
V5 9/25/2019 
showed a short course of oral amoxicillin/clavulanate plus metronidazole was comparable 
to a standard 10-day IV antibiotic course for discharged patients.9 Another study 
suggested that as long as oral intake was tolerated, patients could be discharged with a 7-
day course of oral trimethoprim/sulfamethoxazole, regardless of the presence of 
leukocytosis or fever.15 Another study showed no difference in clinical outcomes in an 
adult patient population where patients were randomized to a fixed 4-day treatment 
duration versus an 8-day regimen.21 The study authors concluded that afebrile patients 
were at low risk for subsequent infections and may not have needed an antibiotic regimen 
at all.14 These results support the overall conclusion that antibiotic regimen may not have 
a significant impact on reducing post-appendectomy abscess rates, even when controlling 
for variation in clinical parameters.4,5,7,9-11,16,21 This research will contribute to the clinical 
management of perforated appendicitis in pediatric patients, post-laparoscopic abscess 
formation, and antibiotic stewardship. 
 
 
 
B. Primary and Secondary Outcomes 
 
The central hypothesis tested in this study is whether a 4-day antibiotics course is 
equivalent to an 8-day course for post-drainage primary and secondary clinical outcomes. 
 
Primary outcomes: 
• readmission rate 
 
Secondary Outcomes: 
• length of stay (LOS) 
• rate of post-drainage surgical site infection until 30 days after discharge 
• rate of post-drainage abdominal abscess until30 days after discharge 
• secondary site infections 
 
 
C. Methods 
 
C.1. Study Design 
This research proposes a randomized, prospective, equivalence trial design to test the 
research hypothesis. This study will demonstrate no difference in clinical outcomes 
between the 4-day antibiotic course and the 8-day course. The study will include 342 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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V5 9/25/2019 
pediatric patients (includes 10% oversampled) ages 2 through 17 years treated from 
February 1, 2019 onward until the study cohorts have been filled. This study is based on 
an expectation of 90% success (10% readmitted) in arm A=10% and expectation of 90% 
success (10% readmitted) in arm B =10%. The clinical difference in primary outcome 
between the two groups that we are prepared to accept is equal or greater than 10% (i.e., 
clinically, we are willing to accept 10 children per 100 who may have benefited from the 
long course but received a short course to achieve 90% of children who received the short 
course and would not have benefitted from a long course). The sample size needed to 
attain a power of 0.80 at alpha=0.05 is 342 (171 in each arm, which includes a 10% 
attrition rate). The risk of type I error is 1-0.95 (alpha=0.05); power=0.80. The study will 
proceed until 171 patients are consented for each arm.  Study personnel will perform an 
interim analysis of the data approximately halfway through study enrollment. 
 
Definition of perforated appendicitis - Perforated appendicitis is defined as a visible hole 
or feces found in the abdomen at laparoscopy.  For purposes of research, either the hole 
or feces is photographed, and“hole,” “feces/stool in the abdomen,” or other note 
describing perforation will need to be specifically described in the operative report. 
Based on estimates from the Division of Pediatric Surgery, PCH performs approximately 
1000 laparoscopic appendectomies annually. Approximately one-third of these 
appendectomies (300) are perforated; about 10%-20% of these 300 perforated patients 
(30-60) will develop a post-surgical abscess treated with a percutaneous drain and IV 
antibiotics. 
 
Screening - The study population is comprised of patients who, upon admission, are 
diagnosed with perforated appendicitis and who, after laparoscopy, form an abscess 
(while still in hospital or discharged and then readmitted with abscess), and are treated 
with percutaneous drainage and IV ceftriaxone/metronidazole or other broad spectrum 
antibiotic equivalent per hospital standard of care. Screened patients will be assigned a 
screening ID, which will be maintained in a screening log. 
 
Randomization - Once eligibility for study inclusion is determined at the time of 
drainage, the patient will be consented by the principal investigator or sub-investigator 
and assigned a study number. A block randomization strategy will be used based on a 
random number generator and applied after consent by site to assign patients to either the 
control (8-day) or experimental (4-day) arm of the study. All patients will be randomly 
assigned by patient study numbers. A current randomized trial underway at Phoenix 
Children’s Hospital requires photography to confirm a diagnosis of perforation (IRB 17-
011). We propose to follow the same approach for verifying perforated appendicitis 
across WSPRC institutions in this study.  When possible, the hole or feces will be 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
V5 9/25/2019 
photographed.  If not, “hole,” “feces/stool in the abdomen,” or other note describing 
perforation will need to be specifically described in the operative report. The two study 
arms will include some patients with abscess that has been confirmed though CT or 
ultrasound as part of standard of care prior to study participation. We will include 
CT/ultrasound results as part of data collection. 
 
Antibiotic regimen - All post-laparoscopic abscess patients will receive the standard of 
care for antibiotic therapy—IV ceftriaxone/metronidazole or other broad spectrum 
antibiotic equivalent —until afebrile (38.5o C) and tolerating food for 24 hours (i.e., 
without vomiting). CBC panels are also standard of care and may be drawn multiple 
times during the patient’s stay. Standard of care at discharge includes prescribed oral, 
empiric, antibiotic therapy (PO), such as ampicillin/clavulanate or other broad spectrum 
antibiotic.  The choice and the duration of broad spectrum antibiotic prescription are at 
the surgeon’s discretion.  
 
In this study, all patients will be treated with the hospital standard of care and receive in-
patient treatment for abscess until afebrile and tolerating food for 24 hours.  After 
percutaneous drainage of the abscess, the patient will be randomly assigned to receive 
either an 8-day regimen (arm A) or a 4-day regimen (arm B) of antibiotics (Diagram 1). 
Patients will remain on IV ceftriaxone/metronidazole or other broad spectrum antibiotic 
equivalent until afebrile and tolerating food for 24 hours.  Patients will complete their 
assigned 4- or 8-day regimen with oral ampicillin clavulanate or other broad spectrum 
antibiotic equivalent.  If patients are not afebrile at the completion of their assigned 
regimen, prescribing an extended course of antibiotics is at the discretion of the treating 
surgeon. A prescribed oral course of antibiotics may be finished in the hospital or at 
home if patient is discharged.   
 
Ampicillin and clavulanate have been safely utilized in previous pediatric 
research.5,10,14,11 These antibiotics have demonstrated clinical equivalence in both 
retrospective studies and prospective trials.9,11 This randomized trial is the first to address 
duration of antibiotic treatment in pediatric patients diagnosed with perforated 
appendicitis and who form a post-laparoscopic abscess. Pediatric patients who are 
allergic to ampicillin will be prescribed another broad-spectrum antibiotic (e.g., 
gentamycin/clindamycin or ciprofloxacin) at the discretion of the treating surgeon. 
 
Two arms are proposed for the study following the protocol implemented for adults in a 
recent randomized trial.21 In the control arm, patients will be treated with an 8-day course 
of antibiotics, and in the experimental arm, patients will be treated with a 4-day course of 
antibiotics. The randomized trial should control for all confounding effects. In addition, 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
V5 9/25/2019 
we will collect clinical data on the pre-operative, peri-operative and post-operative 
antibiotic treatment and number of days on antibiotic therapy prior to discharge to 
manage this potential confounder post hoc. 
 
There is a low probability of study attrition or loss to follow-up. As the primary treatment 
provider in a study with a short (30-day) follow-up period for readmission, we do not 
expect significant attrition. Follow-up will entail tracking all patients from the initial 
study who return to the hospital for complications related to the procedure within 30 days 
of discharge. All complications, including those requiring readmission, will be included 
in the follow-up. All study patients will be assessed for primary and secondary clinical 
outcomes. Complications associated with surgically treated acute appendicitis based on 
the National Surgery Quality Improvement Program criteria (available at 
http://nsqip.healthsoftonline.com/hsi/) include (1) wound infection, (2) abscess, (3) post-
discharge small bowel obstruction, (4) hernia, (5) length of hospital stay of greater than 4 
days, and (6) death. 
 
 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
V5 9/25/2019 
Diagram 1: Treatment arms for randomized trial of an 8-day antibiotic treatment vs. 4-
day treatment of post-laparoscopic abscess formation in pediatric complicated 
(perforated) appendicitis.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complicated (Perforated) Appendicitis 
Age 2-17 years 
N=342 
Laparoscopy within 24 hours of 
admission 
Discharged to Home† 
 
-Afebrile (38.5o C) 
-Food intake ≥ 24 hrs. 
with no vomiting 
Arm A 
 
Antibiotics (IV + PO) 
 
Arm B 
 
Antibiotics (IV + PO) 
 
Post-Operative Abscess 
(either in hospital, or after discharge and then 
readmitted with abscess) 
IV ceftriaxone + metronidazole or other broad 
spectrum antibiotic equivalent 
Percutaneous drainage 
* If febrile after assigned course of antibiotics (i.e., 8 days or 4 days) is completed, extended anitibotic treatment 
will be up to the treating surgeon. 
†Patient may be discharged before 8- or 4-day course is completed and may finish antibiotics at home. 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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V5 9/25/2019 
C.2. Inclusion/Exclusion 
 
Inclusion criteria: 
 
• All patients ages 2 through 17 years treated laparoscopically for perforated 
appendicitis after February 1, 2019 (where perforated appendicitis is defined 
as a photographed hole in the abdomen, as feces in the abdomen, or a specific 
description of either in the operative report), and who developed post-
appendectomy abscess that was treated via percutaneous drainage. 
 
Exclusion criteria: 
 
• Patients who are treated for appendicitis without appendectomy or with a non-
laparoscopic procedure (e.g., drainage only or open appendectomy); 
• Patients being treated with antibiotics for a diagnosis other than abscess during 
their course of treatment (e.g., sinusitis along with abscess); 
• Patients who are treated laparoscopically for perforated appendicitis with 
confirmed post-appendectomy abscess, but the abscess was not treated via 
percutaneous drainage; 
• Patients who are immunocompromised; 
• Patients with Crohn’s disease, ulcerative colitis, or other clinical diagnoses that 
subject the patient to a high-risk of developing intra-abdominal abscess; 
• Patients whom the surgeon believes should not participate for any reason. 
 
C.3. Data Collection 
 
Data will be collected prospectively for all study patients. Patients will be followed until 
30 days post-discharge to assess clinical outcomes. The following will be collected: 
patient and demographic data (e.g., BMI, age, and gender), clinical data (e.g., antibiotic 
route, WBC, CBC pathology report, CT/ultrasound results, symptom duration, diffused 
vs. localized peritonitis, intra-abdominal contamination, maximum temperature prior to 
laparoscopy, LOS, and time to regular diet), and outcomes (e.g., abscess formation after 
drainage, re-hospitalization frequency and duration of each stay, secondary infections, 
and total number of visits after discharge). A CBC with differential will be collected at 
admission and post-laparoscopy if available. CT/ultrasound data will also be collected. 
For a complete list of variables, please refer to the data collection form included as part 
of the IRB application (RCT_Post_Appy_Abscess_DCF1). 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
V5 9/25/2019 
 
It is estimated that it will take about 6 years for PCH to fill the study arms; interim 
analysis will be performed when study cohorts are half-filled. In order to complete this 
and other planned pediatric appendicitis studies more quickly, we are planning to add 
other study sites though the Western Surgical Research Consortium. The multisite 
approval process will be facilitated by Streamlined Multisite Accelerated Resources for 
Trials (SMART) IRB certification. With participation from the nine hospitals in the 
Western Surgical Research Consortium, we would expect to fill the trial cohorts in 
approximately 2 years. 
 
 
C.4. Data Analysis Plan 
 
The study will describe patient and clinical characteristics related to laparoscopy among 
study cohorts (e.g., age, BMI, gender, maximum temperature upon admission, diarrhea at 
presentation, duration of symptoms, and white blood cell count); patient recovery and 
abscess formation (e.g., time to abscess, abscess size if available, time to regular diet, and 
LOS after the drainage); primary clinical outcome (readmission); and secondary clinical 
outcomes (LOS, total visits after discharge, post-drainage occurrence of abscess, and 
post-drainage secondary infection). 
 
All data will be described using descriptive statistics, including means, standard 
deviation, and proportions. Differences among treatment cohorts and on clinical 
outcomes will be assessed using parametric and non-parametric tests as appropriate. 
Factors confounding outcomes will be identified a priori from research and empirically 
via correlational analysis for continuous measures or through non-parametric techniques 
for discrete variables with a Bonferroni correction for multiple comparisons among 
families of statistical tests. Binomial logistical regression will also be used where 
appropriate. Unadjusted odds ratios will be used to identify variables of interest and 
confounding effects for discrete dependent variables of interest. Adjusted odds ratios will 
be used to compare differences among study cohorts and covariates (e.g., age, gender, 
white blood cell count, and BMI), interactions, and confounders as appropriate. Statistical 
significance will be defined as an alpha of 0.05, with two-sided alternative hypothesis 
and a Bonferroni correction for multiple comparison. Data analysis will be performed 
using SPSS and R. 
 
Interim Analysis - At approximately the halfway point of the study (i.e., 171 patients per 
arm), study personnel will undertake an interim analysis.  
 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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V5 9/25/2019 
 
D. Benefit and Risk Assessment 
 
D.1. Risk Assessment: 
 
This study poses minimal risk. There are no additional expected risks of this study related 
to the trial protocol. The study protocol aligns to the current hospital standard of care at 
diagnosis, treatment, and discharge. This study excludes any patient who possesses a 
higher than normal risk of abscess formation. The study also excludes any patient the 
surgeon believes should NOT participate for any reason.  
 
Hospital standard of care currently diagnoses acute perforated appendicitis via 
laparoscopy, which minimizes the risk of over-inclusion (e.g., including a patient who 
does not have perforated appendicitis and post-appendectomy abscess). Photographing at 
laparoscopy when possible also minimizes risk of inadvertent exclusion because patients 
may be asymptomatic for perforation at the time of laparoscopy. The engagement and 
involvement of pediatric surgeons (multiple surgeons at each institution when possible) 
will assure patient safety during the trial. Physician training on the protocol will also 
contribute to study safety and consistency. Finally, we will also follow strict study 
oversight protocol, including adverse event reporting and in accordance with Good 
Clinical Practices (GCP) research guidelines. 
 
This study does not require new or unique diagnostic procedures other than those already 
in use under hospital standard of care. In this study protocol, there are no changes to the 
standard of care for treatment of post-laparoscopy abscess formation—which currently 
includes IV antibiotics and percutaneous drainage until afebrile and tolerating food intake 
for at least 24 hours—and then discharge to home with an oral antibiotic. All study 
patients receive the standard of care until afebrile and eligible for discharge to home. At 
discharge, standard of care  requires attending physicians to determine the regimen for 
patients who have received treatment for post-appendectomy abscess. The principal 
investigator, Dr. Craig Egan, along with other study investigators and research 
coordinators, will provide study oversight. He and the study investigators will also jointly 
determine if interim analyses support closing the study, completing the study, or adding 
another study arm. Specifically, study investigators are considering proposing no 
antibiotic at drainage if this study is successful. 
 
As with any data collection, there is a risk of breach of confidentiality and protected 
health information (PHI). This risk will be minimized by the following measures: 
 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
V5 9/25/2019 
1) Subject identity will be protected and kept confidential by storing all research 
records in a  password-protected file on a HIPAA-compliant, cloud-based server 
(REDCap), with access limited to study personnel; 
2) Subject informed consent/assent statements will include detail on confidentiality 
and protection of confidential health records; 
3) The compiled data used for analysis will have limited PHI and will not be directly 
linkable to individual subjects; 
4) Manuscripts prepared for presentation and journals will be aggregated and will 
not contain any individual PHI or identifiable patient data. 
 
D.2. Benefits Assessment: 
 
There will be no direct patient benefit from this study. This research will benefit clinical 
management by evaluating whether patients achieve significant differences in primary 
and secondary clinical outcomes based on duration of antibiotic treatment at abscess 
drainage. The study results may help lower costs for post-appendectomy patient care, 
improve infection management, and contribute to antibiotic stewardship. 
 
E.  Confidentiality and Protection of Human Subjects 
 
E.1. Data Protection, Privacy, Storage, and Security 
 
In accordance with  standards for human subjects review, the research study team will 
adhere to precautions to protect participant privacy and confidentiality of information. 
Trauma Research will hold the master key of participant names and unique identifiers for 
use in tracking cases, connecting to data from electronic health records (EHRs), and de-
identifying data. All data will be collected by Trauma Research, de-identified, and 
entered into an encrypted, cloud-based, HIPPA-compliant server (REDCap). Trauma 
Research will access the data through the website and download to a secure, password-
protected network drive at PCH for storage and analysis. 
 
Identifiable patient information will be retained only for as long as the data can be 
cleaned, verified, and prepped for data analysis. De-identified data will be maintained for 
up to three months after acceptance of the first scholarly journal article or until study 
closure, whichever comes first.  For data identified for disposal, appropriate measures 
will be taken; electronic data will be deleted from office computers and the primary 
location of storage in the network drive, and hard copies containing data will be shredded 
and disposed of in accordance with PCH policy. 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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V5 9/25/2019 
 
E.2. Standard of Care, Confidentiality, and Privacy 
 
This study includes all patients age 2-17 years old who, upon presentation to the 
emergency department, are treated for acute perforated appendicitis. Standard of care will 
apply to all patients in the study, and no change will be made to the standard of care. In 
accordance with PCH policy and GCP, study protocol will ensure the privacy of study 
participants and the confidentiality of patient data. All patients and their families will be 
consented and counseled in a private room. 
 
E.3. Eligibility Determination, Incentives, and Consent 
 
Patients will be randomly assigned to a study arm once eligibility determination is 
complete and patients are deemed eligible. Patients are eligible if they meet the eligibility 
criteria and are willing to participate. A random number generator will be used to assign 
eligible patients and fill study arms. All patient families will be fully consented in person 
by the pediatric surgeon in English or Spanish; other languages are excluded. 
 
Study personnel, including the attending physician and designated research personnel, 
will participate in the consent/assent process. Patients and their families will be consented 
at multiple points throughout the study (at eligibility/randomization and at drainage). 
Patients old enough to assent (8 years of age or older) will be provided with an assent 
form, and families will be provided with a copy of the signed informed consent/assent 
form(s). 
 
All families with patients age 2-17 years who are diagnosed with acute perforated 
appendicitis confirmed via laparoscopy will be approached at the time of laparoscopy and 
provided with a study information/recruitment sheet. The consent sheet will describe the 
study in detail, its risks and benefits, and the informed consent process. If the patient 
develops a post-appendectomy abscess, the family will be approached to participate in 
the study by the PI/research staff. The patient will be provided with an assent form, and 
the family will be provided with an informed consent form. The PI/research staff will 
consent the family by reviewing the consent form—and the assent form with the patient 
where age-appropriate—and requesting signatures as needed. The family will be 
informed that at any point in the study they may withdraw or decline further 
participation. All consent forms have been developed in accordance with PCH IRB 
protocol (informed consent/assent forms have been submitted in conjunction with this 
protocol). Informed consent/assent forms will be available in Spanish, and all forms will 
include the following required elements: 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
V5 9/25/2019 
 
• The purpose of the informed consent; 
• Identification of the investigator; 
• Description of the study procedures; 
• The voluntary nature of participation; 
• The absence of any penalty for not choosing to participate; 
• The benefits and risks involved in participation; 
• The protection of data confidentiality and privacy; 
• Additional information if the participant has questions; 
• A place to give written consent to participate in a research study. 
 
 
E.4. Data Security 
 
All electronic health records will be kept in a secure folder on a password-protected drive 
on a HIPAA-compliant, secure, cloud-based server (REDCap). Access will be limited to 
study personnel. Confidentiality will be maintained within legal limits. Subject identifiers 
(e.g., name, medical record number, date of birth, and dates of service) will be retained in 
a research file. However, data retained for the study (listed above in “Data Collection”) 
will be assigned an identification code for the database. A master list of study IDs will be 
kept in a separate file maintained by the study coordinator/staff under password 
protection. 
 
Data will not be shared with individuals outside of those listed in the approved IRB 
application. Data will be maintained at all times by none other than the listed individuals 
on a password-secured drive and will only be reported or shared in de-identified form. 
Data will be maintained up to 3 months after the last published article or until study 
closure—whichever comes first—and then destroyed following PCH site policy. 
 
F. Dissemination Plan 
 
The data and analysis from this study will be compiled into a manuscript or several 
manuscripts for publication in peer-reviewed journals, and an abstract may be submitted 
for presentation at a national conference. 
 


IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
13 
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V5 9/25/2019 
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IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
14 
IRB#: 17-055 
V5 9/25/2019 
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IRB#: 17-055 
Title: A prospective randomized trial of antibiotic duration in post-appendectomy abscess 
PI: Craig Egan, MD 
CoI’s: Dan Ostlie, MD, David Notrica, MD; Justin Lee, MD; Ramin Jamshidi, MD; Dorothy Rowe, MD; 
Jae-O Bae, MD; Lisa McMahon, MD; Kathleen Van Leeuwen, MD; Kate Davenport, MD; Mark Molitor, 
MD. 
 
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IRB#: 17-055 
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