Perforated AppendicitisNCT04253899
The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations
A study testing Appendectomy and Observation in people with Perforated Appendicitis, run by Marshall University at 1 site in United States.
Trial summary
Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- Appendectomy and Observation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women of all ages.
- Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
- Formal consent for the present study must be signed by the patient or his/her parents
- Patients with initial presentation of a phlegmon (abscess in evolution)
Who cannot join
- Patients with non-perforated appendicitis
- Presentation with initially non-perforated appendicitis but found perforation at surgery
- Patient with septic shock
- Patients who had previous appendectomy
- Current treatment of malignancy
- Immunocompromised patients
- Positive pregnancy test
- No consent for the study
Trial locations and contacts
1 site in 1 country.
Michael Abdelmasseh, MD contact
United States1 site, 1 recruiting
- Recruiting
Marshall University School of Medicine
Huntington, West Virginia, 25701
Juan Sanabria, MD MSc FACS, 216-647-8399, sanabriaj@marshall.edu
About this study
Official title: The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations
Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.
A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.
- Conditions
- Perforated Appendicitis
- Being tested
- Appendectomy, Observation
- Keywords
- Perforated appendicitis, Pediatric appendicitis, Appendectomy, Appendiceal abscess, Antibiotic Therapy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Interval Appendectomy
ObservationOther
observation and follow up
| Study group | Role | What they receive |
|---|---|---|
| Standard pediatric group: | Active comparator | patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25) Receives: Procedure: Appendectomy |
| Experimental pediatric group: | Experimental | patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25) Receives: Other: Observation |
| Standard adult group: | Active comparator | patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25) Receives: Procedure: Appendectomy |
| Experimental adult group: | Experimental | Patients ≥18 yo with acute perforated appendicitis and observation (n=25) Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine rate and severity of complications after interval appendectomy
Measured: 12 months
Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
Measured: 12 months
Secondary outcomes (2)
Determine the rate of complete response after percutaneous drainage and antibiotic therapy
Measured: 12 months
Determine the mean surgical value (quality/cost) for each group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Feb 2020
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Sanabria, Marshall University
- Investigators
- Juan Sanabria, MD MSc FACS, Principal investigator, Marshall University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253899
- Sponsor's protocol ID
- 1504002-3
- Status last verified
- Apr 2023
- First submitted
- 29 Jan 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations
- ClinicalTrials.gov ID
- NCT04253899
- Acronym / sponsor ID
- 1504002-3
- Conditions
- Perforated Appendicitis
- Keywords
- Perforated appendicitis, Pediatric appendicitis, Appendectomy, Appendiceal abscess, Antibiotic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.
A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard pediatric group: | Active comparator | Procedure: Appendectomypatients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25) |
| Experimental pediatric group: | Experimental | Other: Observationpatients ≤17 yo with acute perforated appendicitis abscess and observation (n=25) |
| Standard adult group: | Active comparator | Procedure: Appendectomypatients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25) |
| Experimental adult group: | Experimental | Other: ObservationPatients ≥18 yo with acute perforated appendicitis and observation (n=25) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women of all ages.
- Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
- Formal consent for the present study must be signed by the patient or his/her parents
- Patients with initial presentation of a phlegmon (abscess in evolution)
Key exclusion criteria (8 listed)
- Patients with non-perforated appendicitis
- Presentation with initially non-perforated appendicitis but found perforation at surgery
- Patient with septic shock
- Patients who had previous appendectomy
- Current treatment of malignancy
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 |
|---|---|---|
| AppendectomyInterval Appendectomy | Procedure or surgery | Standard adult group:, Standard pediatric group: |
| Observationobservation and follow up | Other | Experimental adult group:, Experimental pediatric group: |
Primary outcome
Determine rate and severity of complications after interval appendectomy
Time frame: 12 months
Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
Time frame: 12 months
2 secondary outcomes
Determine the rate of complete response after percutaneous drainage and antibiotic therapy
Time frame: 12 months
Determine the mean surgical value (quality/cost) for each group
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Perforated Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
Active, not recruiting
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Active, not recruitingPhase 2
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Perforated Appendicitis
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.
Michael Abdelmasseh, MD contact
Juan Sanabria, MD MSc FACS principal investigator
Marshall University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appendectomy and Observation in people with Perforated Appendicitis, run by Marshall University 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Sanabria, MD MSc FACS (216 647 8399, sanabriaj@marshall.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine rate and severity of complications after interval appendectomy (time frame: 12 months). The study lists 2 primary outcomes in all. 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 4 Apr 2023.