Trial Outcomes & Findings for Optimal Care of Complicated Appendicitis (NCT NCT03159754)

NCT ID: NCT03159754

Last Updated: 2023-11-28

Results Overview

Total health care cost starting from time of admission was the intention of this outcome measure. However, the institutions potentially involved were unwilling to provide access to any cost data so this could not be analyzed for any length of time.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies.
• Results posted on: 2023-11-28

Participant Flow

Participant milestones

Measure	Early Appendectomy Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Overall Study STARTED	24	12	4
Overall Study COMPLETED	23	12	4
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories

Baseline characteristics by cohort

Measure	Early Appendectomy n=24 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=12 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Total n=40 Participants Total of all reporting groups
Age, Customized 5-7 years	4 Participants n=24 Participants	6 Participants n=12 Participants	2 Participants n=4 Participants	12 Participants n=40 Participants
Age, Customized 8-12 years	11 Participants n=24 Participants	5 Participants n=12 Participants	1 Participants n=4 Participants	17 Participants n=40 Participants
Age, Customized 13-17 years	9 Participants n=24 Participants	1 Participants n=12 Participants	1 Participants n=4 Participants	11 Participants n=40 Participants
Sex: Female, Male Female	9 Participants n=24 Participants	3 Participants n=12 Participants	0 Participants n=4 Participants	12 Participants n=40 Participants
Sex: Female, Male Male	15 Participants n=24 Participants	9 Participants n=12 Participants	4 Participants n=4 Participants	28 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=24 Participants	1 Participants n=12 Participants	0 Participants n=4 Participants	3 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=24 Participants	11 Participants n=12 Participants	4 Participants n=4 Participants	36 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=24 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Other · American Indian or Alaska Native	2 Participants n=23 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=12 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=4 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	2 Participants n=39 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories
Race (NIH/OMB) Other · Asian	0 Participants n=23 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=12 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	1 Participants n=4 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	1 Participants n=39 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories
Race (NIH/OMB) Other · Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=12 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=4 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=39 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories
Race (NIH/OMB) Other · Black or African American	0 Participants n=23 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=12 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=4 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=39 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories
Race (NIH/OMB) Other · White	20 Participants n=23 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	12 Participants n=12 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	3 Participants n=4 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	35 Participants n=39 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories
Race (NIH/OMB) Other · More than one race	0 Participants n=23 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=12 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=4 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=39 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories
Race (NIH/OMB) Other · Unknown or Not Reported	1 Participants n=23 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=12 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	0 Participants n=4 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories	1 Participants n=39 Participants • one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories
Region of Enrollment United States	24 Participants n=24 Participants	12 Participants n=12 Participants	4 Participants n=4 Participants	40 Participants n=40 Participants

PRIMARY outcome

Timeframe: The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies.

Population: No cost data for any participants was able to be procured. Thus this outcome could not be achieved or analyzed in any fashion.

Total health care cost starting from time of admission was the intention of this outcome measure. However, the institutions potentially involved were unwilling to provide access to any cost data so this could not be analyzed for any length of time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During index/initial hospitalization (generally not more than 5-6 weeks)

Number of persons who experience any of a number of specified complications, including new/recurrent abscess, wound infection, small bowel obstruction, or need for a larger operation

Outcome measures

Measure	Early Appendectomy n=24 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=12 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Complications	9 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: During index/initial hospitalization (generally not more than 5-6 weeks)

Population: Data shown is all that is available - multiple individuals' data is not available.

Parents away from work measured in days is presented here. The intention was to collect "missed activity days" for children as well as missed parent work days. However, the question to capture this information referred to school and was determined to be too inconsistent with the way the question may have been interpreted when the survey was given to code reliably.

Outcome measures

Measure	Early Appendectomy n=11 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=4 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=2 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Parents Away From Work	7.6 days Interval 1.0 to 21.0	9.3 days Interval 1.0 to 16.0	3.5 days Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: During index/initial hospitalization (generally not more than 5-6 weeks)

Population: One person's data from the early appendectomy and four persons from the interval appendectomy for this outcome measure is unavailable.

Duration of antibiotic therapy measured in days

Outcome measures

Measure	Early Appendectomy n=23 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=8 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Duration of Antibiotic Therapy	6.3 days Interval 5.0 to 17.0	5.1 days Interval 2.0 to 6.0	5.4 days Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: During index/initial hospitalization (generally not more than 5-6 weeks)

Length of all hospital stays measured in days

Outcome measures

Measure	Early Appendectomy n=24 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=12 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Length of Stay	7.8 days Interval 0.0 to 26.0	7.4 days Interval 2.0 to 32.0	3.5 days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: During index/initial hospitalization (generally not more than 5-6 weeks)

Number of persons with differing numbers of percutaneous drainage procedures

Outcome measures

Measure	Early Appendectomy n=24 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=12 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Number of Percutaneous Drainage Procedures 1 drainage	4 Participants	4 Participants	1 Participants
Number of Percutaneous Drainage Procedures 2 drainage procedures	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During index/initial hospitalization (generally not more than 5-6 weeks)

Number of radiographic imaging studies including ultrasound, CT, and MRI

Outcome measures

Measure	Early Appendectomy n=24 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=12 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Number of Radiographic Imaging Studies	1.96 number of imaging procedures/participant Interval 1.0 to 6.0	2.04 number of imaging procedures/participant Interval 1.0 to 6.0	1.88 number of imaging procedures/participant Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 1 month; for GI QOL; 2 years for Peds QL

Population: population sizes listed represent the full number of surveys collected for 1 month GI QOL; For 2 year Peds QL, only one participant provided data for the Interval and No Appendectomy arms, so it is not shown to preserve confidentiality; similarly for early appendectomy, there was only 1 child (as opposed to teens) who completed the survey, so it is not included either.

Original QOL outcome measure listed was: Quality of life measured by PedsQL 2 years following discharge. Two year data collected was insufficient to allow for any analysis. One month GI QOL data collected, also listed in the protocol, is shown below. GI QoL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. Peds QL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life.

Outcome measures

Measure	Early Appendectomy n=17 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=7 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 Participants Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Quality of Life (PedsQL) 1 month GI QOL	80.18 score on a scale Interval 61.0 to 100.0	88.4 score on a scale Interval 79.0 to 94.0	87.25 score on a scale Interval 76.0 to 97.0
Quality of Life (PedsQL) 2 year Peds QL (parental report)	86.3 score on a scale Interval 59.69 to 100.0	—	—
Quality of Life (PedsQL) 2 year Peds QL teen report	87.34 score on a scale Interval 62.81 to 100.0	—	—

SECONDARY outcome

Timeframe: 2 years; (Although this appears longer than trial duration, study completion date is based on last 2 year survey turned in, and medical record analysis looked a full two years per participant which extended a bit longer.)

Number of persons who experience recurrent appendicitis requiring hospitalization. Because the early appendectomy arm participant by definition have no appendix to infect after surgery, they are not shown below.

Outcome measures

Measure	Early Appendectomy n=12 Participants Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=4 Participants Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Recurrent Appendicitis	2 Participants	0 Participants	—

Adverse Events

Early Appendectomy

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Interval Appendectomy

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

No Appendectomy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Early Appendectomy n=24 participants at risk Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=12 participants at risk Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 participants at risk Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Gastrointestinal disorders Admission for C-Diff	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Reproductive system and breast disorders Testicular Swelling-hydrocele	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
General disorders ED Admission - Fever and Abdominal Pain	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Gastrointestinal disorders Recurrence of Appendicitis	0.00% 0/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	16.7% 2/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.

Other adverse events

Measure	Early Appendectomy n=24 participants at risk Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	Interval Appendectomy n=12 participants at risk Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.	No Appendectomy n=4 participants at risk Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Surgical and medical procedures Abscess and Drain Placement	16.7% 4/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	33.3% 4/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	25.0% 1/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Infections and infestations Abscess	0.00% 0/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	8.3% 1/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Surgical and medical procedures Drain Placement	12.5% 3/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Gastrointestinal disorders Nausea and vomiting	8.3% 2/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
General disorders Abdominal Pain	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	25.0% 1/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
General disorders Headache	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Infections and infestations Persistent Abscess	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Skin and subcutaneous tissue disorders Redness and discomfort around drain exit site	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Gastrointestinal disorders Ileus	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
Infections and infestations Abscess, drainage without drain placement	4.2% 1/24 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/12 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.	0.00% 0/4 • Three months Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.

Additional Information

Steven Bruch, MD

University of Michigan

Phone: 7349368464

Email: sbruch@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place