AppendicitisAPPSYPPNCT05289713
Appendectomy vs. Symptomatic Treatment in Uncomplicated Acute Appendicitis Among Pediatric Patients
A study testing appendectomy in people with Appendicitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. Patients are recruited from all five Finnish university hospitals. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- appendectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFinland
- Study dates
- 10 Mar 2023to Dec 2025
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 7-15 years
- clinical diagnosis of uncomplicated acute appendicitis confirmed by US and/or MRI: adequately visualized appendix with a diameter of 6.1-11.0 mm without evidence of perforation, abscess, appendicolith or tumor suspicion
- CRP ≤ 65 mg/l
Who cannot join
- inability to give informed consent
- age under 7 or over 15 years
- antibiotic administration within 14 days prior to enrolment
- any previous treatment for acute appendicitis
- severe nausea and/or vomiting preventing oral fluid intake
- systemic disease potentially compromising the safety of symptomatic treatment of acute appendicitis (e.g. type 2 diabetes, malignancy, immune deficiency, or a medical condition requiring immunosuppressant medication)
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- diffuse peritonitis or complicated acute appendicitis at imaging (perforation, abscess, appendicolith or tumor suspicion)
- inadequately visualized appendix
- age and sex adjusted BMI over 27 kg/m2 and no MRI performed
- CRP > 65 mg/l.
Trial locations and contacts
1 site in 1 country.
Jenny Puputti contact
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Janne S Suominen
About this study
Official title: A Randomized, Controlled Multicenter Feasibility Pilot Trial on Imaging Confirmed Uncomplicated Acute Appendicitis: Appendectomy vs. Symptomatic Treatment in Pediatric Patients (the APPSYPP) Trial Study Protocol
The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. Patients are recruited from all five Finnish university hospitals. Inclusion criteria are: 1) age 7-15 years, 2) imaging-confirmed uncomplicated acute appendicitis (no appendicolith, perforation, abscess, or tumor suspicion), and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency appendectomy or symptomatic treatment. In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. In order to ensure patient safety, symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. Primary outcome is treatment success at 30 days defined by not fulfilling any of the treatment failure criteria. In the surgery group, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In the symptomatic treatment group, treatment failure is defined as inability to discharge from hospital without appendectomy within 48 hours after randomization with a finding of histopathologically inflamed appendix, appendectomy during the initial hospital stay due to clinical progression of appendicitis with histopathologically and surgically confirmed complicated acute appendicitis, appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or any complication of appendicitis requiring general anesthesia. Predefined secondary outcomes include later appendectomies, recurrence of histopathologically confirmed appendicitis and associated symptoms, postintervention complications, return to normal daily activities, quality of, resolution of appendicitis in US imagining after 1 month of symptomatic treatment, comparison of US and MRI findings at presentation, and differences in serum biomarkers and fecal microbiota composition.
Read the detailed description
While antibiotic treatment is an effective and safe treatment for most adults and children with imaging-confirmed uncomplicated acute appendicitis, emerging evidence further indicates that antibiotics and symptomatic treatment strategies may have similar efficacy and safety in uncomplicated acute appendicitis among adults. There are no randomized studies comparing appendectomy to symptomatic treatment in children.
The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. Patients are recruited from all five Finnish university hospitals. Inclusion criteria are: 1) age 7-15 years, 2) imaging-confirmed uncomplicated acute appendicitis (no appendicolith, perforation, abscess, or tumor suspicion), and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency appendectomy or symptomatic treatment. In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. In order to ensure patient safety, symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. Primary outcome is treatment success at 30 days defined by not fulfilling any of the treatment failure criteria. In the surgery group, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In the symptomatic treatment group, treatment failure is defined as inability to discharge from hospital without appendectomy within 48 hours after randomization with a finding of histopathologically inflamed appendix, appendectomy during the initial hospital stay due to clinical progression of appendicitis with histopathologically and surgically confirmed complicated acute appendicitis, appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or any complication of appendicitis requiring general anesthesia.
The APPSYPP feasibility trial aims to assess the symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis and whether this can safely be studied in a larger patient cohort in the future.
- Conditions
- Appendicitis
- Being tested
- appendectomy
- Keywords
- uncomplicated acute appendicitis, symptomatic treatment, spontaneous resolution
- 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
Laparoscopic appendectomy is performed within 18 hours after randomization in the surgery group. Patients in the symptomatic treatment group are carefully monitored and the same intervention (laparoscopic appendectomy) is performed in case of treatment failure.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. Receives: Procedure: appendectomy |
| Symptomatic treatment | Active comparator | Symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. Receives: Procedure: appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success at 30d follow-up.
Treatment success is defined by not fulfilling any of the following treatment failure criteria.
Treatment failure in the surgery group:
- Normal histopathology of the removed appendix.
- Any complication of acute appendicitis or surgery requiring general anesthesia (GA) within 30 d.
Treatment failure in the symptomatic treatment group:
- Inability to discharge from hospital within 48 h after randomization without appendectomy due to persisting symptoms and unmet discharge criteria with a finding of histopathologically inflamed appendix.
- Appendectomy due to clinical suspicion of progressive appendicitis including increasing pain not responding to the defined non-opioid analgesics during the initial hospital stay with a finding of histopathologically and surgically confirmed complicated acute appendicitis.
- Appendectomy with a histopathologically confirmed acute appendicitis after hospital discharge within 30 d.
- Any complication of AA reiring GA within 30 d.
Measured: 30 days
Secondary outcomes (7)
Postintervention complications
Categorized according to Clavien-Dindo classification (Grades I-V).
Measured: 1 year
Recurrent appendicitis
Recurrence of appendicitis (Histopathological diagnosis).
Measured: 1 year
Recurrent symptoms
The number of emergency department visits or hospitalizations due to symptoms related to appendicitis.
Measured: 1 year
Recovery of normal daily activities
Recovery to normal daily activities, school and sports. Reported in days.
Measured: 1 year
QoL
Quality of life evaluated by PedsQL, a validated questionnaire
Measured: 1 year
Resolution of acute appendicitis
Resolution of acute appendicitis, verified by US imaging.
Measured: 1 month
Comparison of US and MRI in diagnostics
Comparison of US and MRI findings (appendix visibility/normal/uncomplicated/complicated appendicitis) at presentation in the same patient. Percentage (%) of patients with either normal appendix, uncomplicated appendicitis, complicated appendicitis or not visible appendix. Imaging modalities are compared to each other and with histopathological analysis. Whether MRI imaging can improve diagnostics.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start10 Mar 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital
- Responsible party
- Principal investigator, Janne Suominen, Helsinki University Central Hospital
- Investigators
- Janne Suominen, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289713
- Sponsor's protocol ID
- APPSYPP
- Acronym
- APPSYPP
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All research data will be collected using an online REDCap database. Baseline data collection from all patients presenting with suspected acute appendicitis are collected in emergency department and all relevant data during the treatment and follow up.
Publications
Puputti J, Suominen JS, Luoto T, Hiltunen P, Ripatti L, Nikoskelainen M, Nuutinen S, Sinikumpu JJ, Tahkola E, Porela-Tiihonen S, Hurme S, Salminen P, Pakarinen MP. A randomized, controlled multicenter feasibility pilot trial on imaging confirmed uncomplicated acute appendicitis: Appendectomy vs. symptomatic treatment in pediatric patients (the APPSYPP) trial study protocol. Contemp Clin Trials. 2022 Dec;123:106970. doi: 10.1016/j.cct.2022.106970. Epub 2022 Oct 22.
PubMed 36280033
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Multicenter Feasibility Pilot Trial on Imaging Confirmed Uncomplicated Acute Appendicitis: Appendectomy vs. Symptomatic Treatment in Pediatric Patients (the APPSYPP) Trial Study Protocol
- ClinicalTrials.gov ID
- NCT05289713
- Acronym / sponsor ID
- APPSYPP / APPSYPP
- Conditions
- Appendicitis
- Keywords
- uncomplicated acute appendicitis, symptomatic treatment, spontaneous resolution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Mar 2022 (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.
The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. Patients are recruited from all five Finnish university hospitals. Inclusion criteria are: 1) age 7-15 years, 2) imaging-confirmed uncomplicated acute appendicitis (no appendicolith, perforation, abscess, or tumor suspicion), and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency appendectomy or symptomatic treatment. In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. In order to ensure patient safety, symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. Primary outcome is treatment success at 30 days defined by not fulfilling any of the treatment failure criteria. In the surgery group, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In the symptomatic treatment group, treatment failure is defined as inability to discharge from hospital without appendectomy within 48 hours after randomization with a finding of histopathologically inflamed appendix, appendectomy during the initial hospital stay due to clinical progression of appendicitis with histopathologically and surgically confirmed complicated acute appendicitis, appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or any complication of appendicitis requiring general anesthesia. Predefined secondary outcomes include later appendectomies, recurrence of histopathologically confirmed appendicitis and associated symptoms, postintervention complications, return to normal daily activities, quality of, resolution of appendicitis in US imagining after 1 month of symptomatic treatment, comparison of US and MRI findings at presentation, and differences in serum biomarkers and fecal microbiota composition.
Detailed description
While antibiotic treatment is an effective and safe treatment for most adults and children with imaging-confirmed uncomplicated acute appendicitis, emerging evidence further indicates that antibiotics and symptomatic treatment strategies may have similar efficacy and safety in uncomplicated acute appendicitis among adults. There are no randomized studies comparing appendectomy to symptomatic treatment in children.
The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. Patients are recruited from all five Finnish university hospitals. Inclusion criteria are: 1) age 7-15 years, 2) imaging-confirmed uncomplicated acute appendicitis (no appendicolith, perforation, abscess, or tumor suspicion), and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency appendectomy or symptomatic treatment. In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. In order to ensure patient safety, symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. Primary outcome is treatment success at 30 days defined by not fulfilling any of the treatment failure criteria. In the surgery group, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In the symptomatic treatment group, treatment failure is defined as inability to discharge from hospital without appendectomy within 48 hours after randomization with a finding of histopathologically inflamed appendix, appendectomy during the initial hospital stay due to clinical progression of appendicitis with histopathologically and surgically confirmed complicated acute appendicitis, appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or any complication of appendicitis requiring general anesthesia.
The APPSYPP feasibility trial aims to assess the symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis and whether this can safely be studied in a larger patient cohort in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: appendectomyIn the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. |
| Symptomatic treatment | Active comparator | Procedure: appendectomySymptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 7-15 years
- clinical diagnosis of uncomplicated acute appendicitis confirmed by US and/or MRI: adequately visualized appendix with a diameter of 6.1-11.0 mm without evidence of perforation, abscess, appendicolith or tumor suspicion
- CRP ≤ 65 mg/l
Key exclusion criteria (10 listed)
- inability to give informed consent
- age under 7 or over 15 years
- antibiotic administration within 14 days prior to enrolment
- any previous treatment for acute appendicitis
- severe nausea and/or vomiting preventing oral fluid intake
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 |
|---|---|---|
| appendectomyLaparoscopic appendectomy is performed within 18 hours after randomization in the surgery group. Patients in the symptomatic treatment group are carefully monitored and the same intervention (laparoscopic appendectomy) is performed in case of treatment failure. | Procedure or surgery | Surgery, Symptomatic treatment |
Primary outcome
Treatment success at 30d follow-up.
Time frame: 30 days
Treatment success is defined by not fulfilling any of the following treatment failure criteria. Treatment failure in the surgery group: * Normal histopathology of the removed appendix. * Any complication of acute appendicitis or surgery requiring general anesthesia (GA) within 30 d. Treatment failure in the symptomatic treatment group: * Inability to discharge from hospital within 48 h after randomization without appendectomy due to persisting symptoms and unmet discharge criteria with a finding of histopathologically inflamed appendix. * Appendectomy due to clinical suspicion of progressive appendicitis including increasing pain not responding to the defined non-opioid analgesics during the initial hospital stay with a finding of histopathologically and surgically confirmed complicated acute appendicitis. * Appendectomy with a histopathologically confirmed acute appendicitis after hospital discharge within 30 d. * Any complication of AA reiring GA within 30 d.
7 secondary outcomes
Postintervention complications
Time frame: 1 year
Recurrent appendicitis
Time frame: 1 year
Recurrent symptoms
Time frame: 1 year
Recovery of normal daily activities
Time frame: 1 year
QoL
Time frame: 1 year
Resolution of acute appendicitis
Time frame: 1 month
Comparison of US and MRI in diagnostics
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 36280033Puputti J, Suominen JS, Luoto T, Hiltunen P, Ripatti L, Nikoskelainen M, Nuutinen S, Sinikumpu JJ, Tahkola E, Porela-Tiihonen S, Hurme S, Salminen P, Pakarinen MP. A randomized, controlled multicenter feasibility pilot trial on imaging confirmed uncomplicated acute appendicitis: Appendectomy vs. symptomatic treatment in pediatric patients (the APPSYPP) trial study protocol. Contemp Clin Trials. 2022 Dec;123:106970. doi: 10.1016/j.cct.2022.106970. Epub 2022 Oct 22.
- Individual participant dataSharing planned: Yes. All research data will be collected using an online REDCap database. Baseline data collection from all patients presenting with suspected acute appendicitis are collected in emergency department and all relevant data during the treatment and follow up.
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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.
Jenny Puputti contact
Janne Suominen, MD, PhD principal investigator
Helsinki University Central 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 appendectomy in people with Appendicitis, run by Helsinki University Central Hospital at 1 site in Finland.
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 10 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 26 Sep 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 Finland. 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 Janne Suominen, MD, PhD (+358504272977, janne.suominen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success at 30d follow-up. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289713, which also lists 1 linked publication.
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 26 Sep 2023.