Suppurative AppendicitisNCT02137603
Fast Track Appendectomy for Suppurative Appendicitis
A study testing Patients discharged home the same day following appendectomy in people with Suppurative Appendicitis, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Suppurative Appendicitis
- What is being tested?
- Patients discharged home the same day following appendectomy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged 5-18
- Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800.
- Intraoperative findings of suppurative appendicitis
Who cannot join
- Pregnancy
- Complex medical history not appropriate for same day discharge
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Fast Track Appendectomy in Pediatric Patients With Intraoperative Findings of Suppurative Appendicitis
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.
- Conditions
- Suppurative Appendicitis
- Being tested
- Patients discharged home the same day following appendectomy
- Keywords
- Suppurative appendicitis, appendicitis, pediatric
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients discharged home the same day following appendectomyOther
Patients are discharged to home on the same day following appendectomy with oral antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Fast track | Experimental | Patients discharged home the same day following appendectomy Receives: Other: Patients discharged home the same day following appendectomy |
| Admission | No intervention | Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Length of Stay
Measured: 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
Measured: Thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suppurative AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole M Chandler, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137603
- Sponsor's protocol ID
- 13-0660
- Status last verified
- Jun 2023
- First submitted
- 7 May 2014
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Appendectomy in Pediatric Patients With Intraoperative Findings of Suppurative Appendicitis
- ClinicalTrials.gov ID
- NCT02137603
- Acronym / sponsor ID
- 13-0660
- Conditions
- Suppurative Appendicitis
- Keywords
- Suppurative appendicitis, appendicitis, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 15 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast track | Experimental | Other: Patients discharged home the same day following appendectomyPatients discharged home the same day following appendectomy |
| Admission | No intervention | –Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients aged 5-18
- Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800.
- Intraoperative findings of suppurative appendicitis
Key exclusion criteria (2 listed)
- Pregnancy
- Complex medical history not appropriate for same day discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients discharged home the same day following appendectomyPatients are discharged to home on the same day following appendectomy with oral antibiotics. | Other | Fast track |
Primary outcome
Post Operative Length of Stay
Time frame: Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
1 secondary outcome
Thirty Day Complication Rate
Time frame: Thirty days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Suppurative Appendicitis
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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Re-assessment of Appendicitis Evaluation During Laparoscopic Appendectomy, Peritoneal Irrigation During Laparoscopic Appendectomy Does the Grade of Contamination Matter?
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APPI-Cost Trial for Perforated Appendicitis
Perforated Appendicitis
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Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
Appendicitis Acute, Appendicitis Perforated
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole M Chandler, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients discharged home the same day following appendectomy in people with Suppurative Appendicitis, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Length of Stay (time frame: Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.