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CompletedNCT02137603Updated Jul 3, 2023Results posted

Fast Track Appendectomy for Suppurative Appendicitis

An interventional study of Patients discharged home the same day following appendectomy in Suppurative Appendicitis, sponsored by Johns Hopkins All Children's Hospital. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by Johns Hopkins All Children's Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study summary

The literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. There is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. The current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. Patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. We hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.

02

Conditions studied

  • Suppurative Appendicitis

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Keywords

  • Suppurative appendicitis, appendicitis, pediatric
03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's enrollment of 36 is below the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Johns Hopkins All Children's Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pediatric patients aged 5-18
  • Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800.
  • Intraoperative findings of suppurative appendicitis

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Complex medical history not appropriate for same day discharge
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Fast track

    Patients discharged home the same day following appendectomy

    Other: Patients discharged home the same day following appendectomy

  • No intervention
    Admission

    Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.

Interventions

  • OtherPatients discharged home the same day following appendectomy

    Patients are discharged to home on the same day following appendectomy with oral antibiotics.

06

What researchers measure

Primary outcomes

  1. Post Operative Length of Stay

    Time frame: Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours

Secondary outcomes

  1. Thirty Day Complication Rate

    Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation

    Time frame: Thirty days

07

Results

Posted Sep 15, 2015
Limitations and caveats
The small number of patients enrolled in each arm and the low number of 30-day patient follow up limit the interpretation of the current results.

Participant flow

Participant flow — Overall Study
MilestoneFast TrackAdmission
Started1818
Completed1618
Not completed20

Outcome measures

PrimaryPost Operative Length of Stay
Time frame:
Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
Reported as:
Mean · Hours
Post Operative Length of Stay
HoursFast TrackAdmission
Post Operative Length of Stay8.2 ± 18.723.4 ± 4.2
SecondaryThirty Day Complication Rate

Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation

Time frame:
Thirty days
Reported as:
Number · participants
Thirty Day Complication Rate
participantsFast TrackAdmission
Thirty Day Complication Rate21

Adverse events

Collected over Thirty days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fast Track—0/18 (0%)0/18 (0%)
Admission—0/18 (0%)0/18 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Fast TrackAdmissionTotal
<=18 years181836
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Fast TrackAdmissionTotal
Mean10.8 ± 3.411.6 ± 3.511.2 ± 3.4
Sex: Female, Male
Sex: Female, Male(Participants)Fast TrackAdmissionTotal
Female8513
Male101323
Region of Enrollment
Region of Enrollment(participants)Fast TrackAdmissionTotal
United States181836
08

Study locations

1 site
  • Johns Hopkins All Children's Hospital
    Saint Petersburg, Florida 33701, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2015, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2014
First posted
May 14, 2014
Start
Apr 2014
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Results first posted
Sep 15, 2015
Last update
Jul 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02137603
Lead sponsor
Johns Hopkins All Children's Hospital
Responsible party
Sponsor
First posted
May 14, 2014
Start date
Apr 2014
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Sep 15, 2015
Last update
Jul 3, 2023

Study contacts

Nicole M Chandler, MD
principal investigator · Johns Hopkins All Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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