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NCT Number: NCT06083064

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUS, Jorvi Hospital, Espoo, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspicion of appendicitis

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

Treatment and study plan

Abdominal imaging

Diagnostic Test

Abdominal ultrasound and/or abdominal CT

Score based selective abdominal imaging

Other

Abdominal imaging is done selectively based on Adult Appendicitis Score

Score based selective observation combined with selective abdominal imaging

Other

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

Primary outcomes

  1. Negative appendectomy

    Time frame: Within 30 days from randomization

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

  2. Complicated appendicitis

    Time frame: Within 30 days from randomization

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

Secondary outcomes

  1. histologically proven appendicitis

    Time frame: Within 30 days from randomization

    Number of patients with histologically proven appendicitis undergoing surgery

  2. CT scan

    Time frame: Within 30 days from randomization

    Number of patients having abdominal computed tomography

  3. Adverse events

    Time frame: Within one year from randomization

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

  4. Appendicitis

    Time frame: Within 2 years from randomization

    Number of patients diagnosed with appendicitis

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

    Time frame: During the first 30 days from randomization

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

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

    Time frame: During the first 30 days from randomization

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

  7. Costs in Euros

    Time frame: During the first 30 days from randomization

    Overall costs of diagnostics and treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Panu Mentula, MD

CONTACT

[email protected]

504270183 ext. +358

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Acronym: PROSECCO

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Oct 13, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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