AppendicitisPhase 4NCT03159754
Optimal Care of Complicated Appendicitis
A Phase 4 study testing Early Appendectomy, Interval Appendectomy and Antibiotics in people with Appendicitis and Perforated Appendicitis, run by University of Michigan at 1 site in United States.
Trial summary
When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the infection and inflammation get worse, the appendix can die or burst, leading to a larger infection or even pus pockets around the appendix. This is called complicated, or perforated, appendicitis. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Appendicitis, Perforated Appendicitis, Ruptured Appendicitis
- What is being tested?
- Early Appendectomy, Interval Appendectomy and Antibiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2017to 26 Mar 2020
- Phase
- Phase 4
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least 1 of the following CT or MRI findings:
- Peri-appendicular abscess
- Extruded appendicolith
- Visible hole in appendiceal wall
- Free peritoneal air
- OR
Show all 10Show fewer
- CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3 of the following (with CT) or 2 of 3 of the following (with MRI) *:
- White blood cell count (WBC) >15
- Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign, percussion tenderness, and/or rebound tenderness)
- Temperature > 38.0 C *>90% specificity for complicated appendicitis based on unpublished institutional data
Who cannot join
- Immunocompromized state
- History of major abdominal operation
- Previous appendicitis
- Major comorbidities that preclude safe operation
- Inability to follow-up or appropriately consent
- Pregnant women
Show all 11Show fewer
- Allergy to penicillin plus any one of the following:
- Hypersensitivity to ciprofloxacin and/or metronidazole
- Pregnant/lactating women
- Patients taking theophylline
- Patient taking tizanidine
Trial locations and contacts
1 site in 1 country.
About this study
When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the infection and inflammation get worse, the appendix can die or burst, leading to a larger infection or even pus pockets around the appendix. This is called complicated, or perforated, appendicitis. Three common treatments for complicated appendicitis are
- appendectomy (removal of the appendix) right away
- appendectomy several weeks after the diagnosis
- treating the appendicitis without performing an appendectomy
This study seeks to determine which of these three approaches is most cost-effective in children with complicated appendicitis.
Read the detailed description
This is a single center, prospective study to compare early appendectomy vs. non-operative management of immunocompetent patients with complicated appendicitis, and then to compare interval appendectomy vs. no interval appendectomy in those managed with the initial non-operative approach. Patients who choose early appendectomy will have surgery within 24 hours of diagnosis and be discharged once they are afebrile for 24 hours, have a normal WBC count, and can tolerate a diet. They will be discharged with 5 days of oral ciprofloxacin and metronidazole and follow-up in clinic 2-4 weeks later. Patients who choose non-operative management will receive piperacillin-tazobactam with or without abscess drainage until they are afebrile 24 hours with a normal WBC count and are tolerating a diet, followed by 5 days of oral ciprofloxacin and metronidazole upon discharge. These patients will then be seen in clinic in 2-4 weeks, at which time they will be given the choice of whether or not to undergo interval appendectomy at least 8 weeks from initial presentation. Those in the interval appendectomy group will follow-up one month post-operatively. Patients in both groups will be contacted 3 months and 2 years following initial presentation.
{{{While 40 participants were enrolled as intended, and some data was collected from them, a combination of staff turnover and subsequent resource constraints did not permit the analysis originally intended. Thus, results data is shown comparing the early appendectomy participants against the other two arms combined.}}}}
- Being tested
- Early Appendectomy, Interval Appendectomy, Antibiotics
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early AppendectomyProcedure or surgery
Removal of the appendix within 24 hours of admission
Interval AppendectomyProcedure or surgery
Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.
AntibioticsDrug
Also called Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazole
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
| Study group | Role | What they receive |
|---|---|---|
| Early Appendectomy | Experimental | Not described Receives: Procedure: Early Appendectomy; Drug: Antibiotics |
| Interval Appendectomy | Experimental | Not described Receives: Procedure: Interval Appendectomy; Drug: Antibiotics |
| No Appendectomy | Experimental | Not described Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Cost of Care
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.
Measured: 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.
Secondary outcomes (8)
Complications
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
Measured: During index/initial hospitalization (generally not more than 5-6 weeks)
Parents Away From Work
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.
Measured: During index/initial hospitalization (generally not more than 5-6 weeks)
Duration of Antibiotic Therapy
Duration of antibiotic therapy measured in days
Measured: During index/initial hospitalization (generally not more than 5-6 weeks)
Length of Stay
Length of all hospital stays measured in days
Measured: During index/initial hospitalization (generally not more than 5-6 weeks)
Number of Percutaneous Drainage Procedures
Number of persons with differing numbers of percutaneous drainage procedures
Measured: During index/initial hospitalization (generally not more than 5-6 weeks)
Number of Radiographic Imaging Studies
Number of radiographic imaging studies including ultrasound, CT, and MRI
Measured: During index/initial hospitalization (generally not more than 5-6 weeks)
Quality of Life (PedsQL)
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.
Measured: 1 month; for GI QOL; 2 years for Peds QL
Recurrent Appendicitis
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.
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start29 Jun 2017
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
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 AppendicitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven W. Bruch, University of Michigan
- Investigators
- Steven W. Bruch, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159754
- Sponsor's protocol ID
- HUM00103791
- Status last verified
- Nov 2023
- First submitted
- 17 May 2017
- Last updated
- 28 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Care of Complicated Appendicitis
- ClinicalTrials.gov ID
- NCT03159754
- Acronym / sponsor ID
- HUM00103791
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 28 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the infection and inflammation get worse, the appendix can die or burst, leading to a larger infection or even pus pockets around the appendix. This is called complicated, or perforated, appendicitis. Three common treatments for complicated appendicitis are
- appendectomy (removal of the appendix) right away
- appendectomy several weeks after the diagnosis
- treating the appendicitis without performing an appendectomy
This study seeks to determine which of these three approaches is most cost-effective in children with complicated appendicitis.
Detailed description
This is a single center, prospective study to compare early appendectomy vs. non-operative management of immunocompetent patients with complicated appendicitis, and then to compare interval appendectomy vs. no interval appendectomy in those managed with the initial non-operative approach. Patients who choose early appendectomy will have surgery within 24 hours of diagnosis and be discharged once they are afebrile for 24 hours, have a normal WBC count, and can tolerate a diet. They will be discharged with 5 days of oral ciprofloxacin and metronidazole and follow-up in clinic 2-4 weeks later. Patients who choose non-operative management will receive piperacillin-tazobactam with or without abscess drainage until they are afebrile 24 hours with a normal WBC count and are tolerating a diet, followed by 5 days of oral ciprofloxacin and metronidazole upon discharge. These patients will then be seen in clinic in 2-4 weeks, at which time they will be given the choice of whether or not to undergo interval appendectomy at least 8 weeks from initial presentation. Those in the interval appendectomy group will follow-up one month post-operatively. Patients in both groups will be contacted 3 months and 2 years following initial presentation.
{{{While 40 participants were enrolled as intended, and some data was collected from them, a combination of staff turnover and subsequent resource constraints did not permit the analysis originally intended. Thus, results data is shown comparing the early appendectomy participants against the other two arms combined.}}}}
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Appendectomy | Experimental | Procedure: Early Appendectomy, Drug: Antibiotics |
| Interval Appendectomy | Experimental | Procedure: Interval Appendectomy, Drug: Antibiotics |
| No Appendectomy | Experimental | Drug: Antibiotics |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- At least 1 of the following CT or MRI findings:
- OR
- CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3 of the following (with CT) or 2 of 3 of the following (with MRI) *:
Key exclusion criteria (11 listed)
- Immunocompromized state
- History of major abdominal operation
- Previous appendicitis
- Major comorbidities that preclude safe operation
- Inability to follow-up or appropriately consent
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 |
|---|---|---|
| Early AppendectomyRemoval of the appendix within 24 hours of admission | Procedure or surgery | Early Appendectomy |
| Interval AppendectomyRemoval of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. | Procedure or surgery | Interval Appendectomy |
| AntibioticsAlso: Zosyn (piperacillin/tazobactam); ciprofloxacin; metronidazoleZosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. | Drug | Early Appendectomy, Interval Appendectomy, No Appendectomy |
Primary outcome
Overall Cost of Care
Time frame: 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.
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.
8 secondary outcomes
Complications
Time frame: During index/initial hospitalization (generally not more than 5-6 weeks)
Parents Away From Work
Time frame: During index/initial hospitalization (generally not more than 5-6 weeks)
Duration of Antibiotic Therapy
Time frame: During index/initial hospitalization (generally not more than 5-6 weeks)
Length of Stay
Time frame: During index/initial hospitalization (generally not more than 5-6 weeks)
Number of Percutaneous Drainage Procedures
Time frame: During index/initial hospitalization (generally not more than 5-6 weeks)
Number of Radiographic Imaging Studies
Time frame: During index/initial hospitalization (generally not more than 5-6 weeks)
Quality of Life (PedsQL)
Time frame: 1 month; for GI QOL; 2 years for Peds QL
Recurrent Appendicitis
Time frame: 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.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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.
Steven W. Bruch, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early Appendectomy, Interval Appendectomy and Antibiotics in people with Appendicitis and Perforated Appendicitis, run by University of Michigan 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 10 inclusion and 11 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 28 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2023). 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?
Overall Cost of Care (time frame: 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.). 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 28 Nov 2023.