ClinicalTrials.gg
RecruitingNCT06083064PROSECCOUpdated Sep 18, 2026

Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis

An interventional study of Abdominal imaging and Score based selective abdominal imaging in Appendicitis, sponsored by Helsinki University Central Hospital. Recruiting at 3 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Appendicitis

Browse trials for

03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 900 is above the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Suspicion of appendicitis

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (estimated)

Study arms

  • Active comparator
    Routine imaging

    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.

    Diagnostic Test: Abdominal imaging

  • Experimental
    Adult Appendicitis Score based selective imaging

    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.

    Other: Score based selective abdominal imaging

  • Experimental
    Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score

    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.

    Other: Score based selective observation combined with selective abdominal imaging

Interventions

  • Diagnostic testAbdominal imaging

    Abdominal ultrasound and/or abdominal CT

  • OtherScore based selective abdominal imaging

    Abdominal imaging is done selectively based on Adult Appendicitis Score

  • OtherScore based selective observation combined with selective abdominal imaging

    Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging

06

What researchers measure

Primary outcomes

  1. Negative appendectomy

    Number of negative appendectomies (surgical removal of non-inflamed appendix)

    Time frame: Within 30 days from randomization

  2. Complicated appendicitis

    Number of patients with complicated appendicitis (AAST grade 3 or higher)

    Time frame: Within 30 days from randomization

Secondary outcomes

  1. histologically proven appendicitis

    Number of patients with histologically proven appendicitis undergoing surgery

    Time frame: Within 30 days from randomization

  2. CT scan

    Number of patients having abdominal computed tomography

    Time frame: Within 30 days from randomization

  3. Adverse events

    Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)

    Time frame: Within one year from randomization

  4. Appendicitis

    Number of patients diagnosed with appendicitis

    Time frame: Within 2 years from randomization

  5. Quality of life (EQ-5D-5L index value)

    Quality of life determined by weekly EQ-5D-5L index values.

    Time frame: During the first 30 days from randomization

  6. Quality of life (EQ-5D-5L EQ-VAS score)

    Quality of life determined by weekly EQ-5D-5L EQ-VAS score.

    Time frame: During the first 30 days from randomization

  7. Costs in Euros

    Overall costs of diagnostics and treatment

    Time frame: During the first 30 days from randomization

07

Study locations

3 of 3 sites recruiting
  • HUS, Jorvi Hospital
    Espoo, Finland
    Recruiting
    • Hanna Lampela, MD · Contact
  • HUS, Meilahti Hospital
    Helsinki, 00029, Finland
    Recruiting
    • Panu J Mentula, MD · Contact
    • Panu Mentula, MD · Principal investigator
    • Ville Sallinen, MD · Sub investigator
    • Kirsi Lastunen, MD · Sub investigator
  • HUS, Hyvinkää Hospital
    Hyvinkää, Finland
    Recruiting
    • Hanna Koppatz, MD · Contact
08

References and documents

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 24970111 ↗
  • Lastunen 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 35482016 ↗
  • Atema 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06083064
Responsible party
Panu Mentula (M.D., Helsinki University Central Hospital) — Principal investigator
First posted
Oct 13, 2023
Start date
Nov 15, 2023
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Sep 18, 2026

Study contacts

Panu Mentula, MD
Contact
panu.mentula@hus.fi
504270183 ext. +358
Panu Mentula, MD
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion