AppendicitisPROSECCONCT06083064
Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis
A study testing Abdominal imaging, Score based selective abdominal imaging and Score based selective observation combined with selective abdominal imaging in people with Appendicitis, run by Helsinki University Central Hospital at 3 sites in Finland.
Trial summary
The goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question[s] it aims to answer are: Does protocol based selective imaging using clinical scoring affect clinical outcome? Does protocol based selective observation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- Abdominal imaging, Score based selective abdominal imaging and Score based selective observation combined with selective abdominal imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesFinland
- Study dates
- 15 Nov 2023to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspicion of appendicitis
Who cannot join
- Time from symptom onset over 72 hours
- Age <18 years
- Pregnancy, ruled out by serum or urine HCG measurement in 18- to 49-year-old women
- CT-scan or ultrasound already done within the last 3 days (72 hours)
- Clinical suspicion of other disease or other reason to perform imaging study
- Recruited earlier to the same trial
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland3 sites, 3 recruiting
- Recruiting
HUS, Jorvi Hospital
Espoo
Hanna Lampela, MD
- Recruiting
HUS, Meilahti Hospital
Helsinki, 00029
Panu J Mentula, MD
Panu Mentula, MD
- Recruiting
HUS, Hyvinkää Hospital
Hyvinkää
Hanna Koppatz, MD
About this study
Official title: Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
The goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question[s] it aims to answer are:
- Does protocol based selective imaging using clinical scoring affect clinical outcome?
- Does protocol based selective observation combined with score based selective imaging affect clinical outcome?
Read more
Participants will be randomized into three groups:
- Selective imaging based on Adult Appendicitis Score
- Selective observation based on Appendicitis Severity Score combined with selective imaging based on Adult Appendicitis Score
- Routine imaging using ultrasound and/or computed tomography
Researchers will compare selective imaging groups separately with routine imaging to see if number of negative appendectomies or number of complicated appendicitis is not significantly increased.
- Conditions
- Appendicitis
- Being tested
- Abdominal imaging, Score based selective abdominal imaging, Score based selective observation combined with selective abdominal imaging
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal imagingDiagnostic test
Abdominal ultrasound and/or abdominal CT
Score based selective abdominal imagingOther
Abdominal imaging is done selectively based on Adult Appendicitis Score
Score based selective observation combined with selective abdominal imagingOther
Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging
| Study group | Role | What they receive |
|---|---|---|
| Routine imaging | Active comparator | Patients will have first abdominal ultrasound, and if findings are negative or inconclusive for appendicitis abdominal CT scan is made. If ultrasound is not available, CT scan can be the first imaging study. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Other patients are discharged or treated according to possible alternative diagnosis. Receives: Diagnostic Test: Abdominal imaging |
| Adult Appendicitis Score based selective imaging | Experimental | Adult Appendicitis Score (AAS) is calculated as soon as possible. Patients with AAS 16 or higher are scheduled for urgent laparoscopic appendectomy. Patients with AAS 11- 15 will have abdominal imaging as in the group 1. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Patients with AAS 10 or less are discharged without imaging studies. Receives: Other: Score based selective abdominal imaging |
| Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score | Experimental | Patients with Adult Appendicitis Score (AAS) 10 or less are discharged without imaging studies. Patients with AAS 11 or more are managed based on Appendicitis Severity Score (ASS). ASS is used to identify patients with low risk of complicated disease. Patients with high ASS (>4) are managed as patients in arm 2. Patients with low ASS (<=4) begin observation protocol where patients can leave hospital and they are re-evaluated with repeated scoring after 12-24 hours from randomization. After re-scoring patients may be discharged if AAS is below 16 and decreasing and ASS is below 5 or if AAS is below 11. If AAS is 16 or higher or increasing, patients are scheduled for urgent laparoscopic appendectomy. After observation period, patients with decreasing AAS between 11-15 and ASS higher than 4 or patients with stable AAS between 11-15 are send for imaging study. Receives: Other: Score based selective observation combined with selective abdominal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative appendectomy
Number of negative appendectomies (surgical removal of non-inflamed appendix)
Measured: Within 30 days from randomization
Complicated appendicitis
Number of patients with complicated appendicitis (AAST grade 3 or higher)
Measured: Within 30 days from randomization
Secondary outcomes (7)
histologically proven appendicitis
Number of patients with histologically proven appendicitis undergoing surgery
Measured: Within 30 days from randomization
CT scan
Number of patients having abdominal computed tomography
Measured: Within 30 days from randomization
Adverse events
Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)
Measured: Within one year from randomization
Appendicitis
Number of patients diagnosed with appendicitis
Measured: Within 2 years from randomization
Quality of life (EQ-5D-5L index value)
Quality of life determined by weekly EQ-5D-5L index values.
Measured: During the first 30 days from randomization
Quality of life (EQ-5D-5L EQ-VAS score)
Quality of life determined by weekly EQ-5D-5L EQ-VAS score.
Measured: During the first 30 days from randomization
Costs in Euros
Overall costs of diagnostics and treatment
Measured: During the first 30 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Nov 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panu Mentula, Helsinki University Central Hospital
- Investigators
- Panu Mentula, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083064
- Sponsor's protocol ID
- HUS/74/2023
- Acronym
- PROSECCO
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114.
PubMed 24970111Lastunen KS, Leppaniemi AK, Mentula PJ. DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial. Br J Surg. 2022 Jun 14;109(7):588-594. doi: 10.1093/bjs/znac120.
PubMed 35482016Atema JJ, van Rossem CC, Leeuwenburgh MM, Stoker J, Boermeester MA. Scoring system to distinguish uncomplicated from complicated acute appendicitis. Br J Surg. 2015 Jul;102(8):979-90. doi: 10.1002/bjs.9835. Epub 2015 May 12.
PubMed 25963411
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
- ClinicalTrials.gov ID
- NCT06083064
- Acronym / sponsor ID
- PROSECCO / HUS/74/2023
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 13 Oct 2023 (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 goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question[s] it aims to answer are:
- Does protocol based selective imaging using clinical scoring affect clinical outcome?
- Does protocol based selective observation combined with score based selective imaging affect clinical outcome?
Participants will be randomized into three groups:
- Selective imaging based on Adult Appendicitis Score
- Selective observation based on Appendicitis Severity Score combined with selective imaging based on Adult Appendicitis Score
- Routine imaging using ultrasound and/or computed tomography
Researchers will compare selective imaging groups separately with routine imaging to see if number of negative appendectomies or number of complicated appendicitis is not significantly increased.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1
| Arm | Type | Receives |
|---|---|---|
| Routine imaging | Active comparator | Diagnostic Test: Abdominal imagingPatients will have first abdominal ultrasound, and if findings are negative or inconclusive for appendicitis abdominal CT scan is made. If ultrasound is not available, CT scan can be the first imaging study. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Other patients are discharged or treated according to possible alternative diagnosis. |
| Adult Appendicitis Score based selective imaging | Experimental | Other: Score based selective abdominal imagingAdult Appendicitis Score (AAS) is calculated as soon as possible. Patients with AAS 16 or higher are scheduled for urgent laparoscopic appendectomy. Patients with AAS 11- 15 will have abdominal imaging as in the group 1. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Patients with AAS 10 or less are discharged without imaging studies. |
| Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score | Experimental | Other: Score based selective observation combined with selective abdominal imagingPatients with Adult Appendicitis Score (AAS) 10 or less are discharged without imaging studies. Patients with AAS 11 or more are managed based on Appendicitis Severity Score (ASS). ASS is used to identify patients with low risk of complicated disease. Patients with high ASS (>4) are managed as patients in arm 2. Patients with low ASS (<=4) begin observation protocol where patients can leave hospital and they are re-evaluated with repeated scoring after 12-24 hours from randomization. After re-scoring patients may be discharged if AAS is below 16 and decreasing and ASS is below 5 or if AAS is below 11. If AAS is 16 or higher or increasing, patients are scheduled for urgent laparoscopic appendectomy. After observation period, patients with decreasing AAS between 11-15 and ASS higher than 4 or patients with stable AAS between 11-15 are send for imaging study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspicion of appendicitis
Key exclusion criteria (6 listed)
- Time from symptom onset over 72 hours
- Age <18 years
- Pregnancy, ruled out by serum or urine HCG measurement in 18- to 49-year-old women
- CT-scan or ultrasound already done within the last 3 days (72 hours)
- Clinical suspicion of other disease or other reason to perform imaging study
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 |
|---|---|---|
| Abdominal imagingAbdominal ultrasound and/or abdominal CT | Diagnostic test | Routine imaging |
| Score based selective abdominal imagingAbdominal imaging is done selectively based on Adult Appendicitis Score | Other | Adult Appendicitis Score based selective imaging |
| Score based selective observation combined with selective abdominal imagingObservation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging | Other | Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score |
Primary outcome
Negative appendectomy
Time frame: Within 30 days from randomization
Number of negative appendectomies (surgical removal of non-inflamed appendix)
Complicated appendicitis
Time frame: Within 30 days from randomization
Number of patients with complicated appendicitis (AAST grade 3 or higher)
7 secondary outcomes
histologically proven appendicitis
Time frame: Within 30 days from randomization
CT scan
Time frame: Within 30 days from randomization
Adverse events
Time frame: Within one year from randomization
Appendicitis
Time frame: Within 2 years from randomization
Quality of life (EQ-5D-5L index value)
Time frame: During the first 30 days from randomization
Quality of life (EQ-5D-5L EQ-VAS score)
Time frame: During the first 30 days from randomization
Costs in Euros
Time frame: During the first 30 days from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 24970111Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114.
- Background: PubMed 35482016Lastunen KS, Leppaniemi AK, Mentula PJ. DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial. Br J Surg. 2022 Jun 14;109(7):588-594. doi: 10.1093/bjs/znac120.
- Background: PubMed 25963411Atema JJ, van Rossem CC, Leeuwenburgh MM, Stoker J, Boermeester MA. Scoring system to distinguish uncomplicated from complicated acute appendicitis. Br J Surg. 2015 Jul;102(8):979-90. doi: 10.1002/bjs.9835. Epub 2015 May 12.
- Individual participant dataSharing planned: No
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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.
Panu Mentula, MD principal investigator
Helsinki University Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal imaging, Score based selective abdominal imaging and Score based selective observation combined with selective abdominal imaging in people with Appendicitis, run by Helsinki University Central Hospital at 3 sites 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panu Mentula, MD (504270183 ext. +358, panu.mentula@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative appendectomy (time frame: Within 30 days from randomization). 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?
On the ClinicalTrials.gov record for NCT06083064, which also lists 3 linked publications.
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 18 Sep 2026.