Trial Outcomes & Findings for Non-operative Management of Pediatric Appendicitis With an Appendicoltih (NCT NCT02189668)

NCT ID: NCT02189668

Last Updated: 2018-11-27

Results Overview

Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-11-27

Participant Flow

Participant milestones

Measure	Non-operative Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic	Surgery Usual care with urgent appendectomy
Overall Study STARTED	5	9
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Baseline characteristics by cohort

Measure	Non-operative n=5 Participants Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic	Surgery n=9 Participants Usual care with urgent appendectomy	Total n=14 Participants Total of all reporting groups
Age, Continuous	14 years n=5 Participants	11 years n=7 Participants	12 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge

Outcome measures

Measure	Non-operative n=5 Participants Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic	Surgery n=9 Participants Usual care with urgent appendectomy
Number of Participants That Did Not Have an Appendectomy	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 year

Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.

Outcome measures

Measure	Non-operative n=5 Participants Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic	Surgery n=9 Participants Usual care with urgent appendectomy
Number of Participants With Complicated Appendicitis	0 Participants	6 Participants

Adverse Events

Non-operative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Minneci

Nationwide Children's Hospital

Phone: 6147223066

Email: peter.minneci@nationwidechildrens.org

Results disclosure agreements

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