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

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?

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 Overview

• Status: Recruiting
• Conditions: Appendicitis
• Intervention / Treatment: Diagnostic test: Abdominal imaging; Other: Score based selective abdominal imaging; Other: Score based selective observation combined with selective abdominal imaging

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Panu Mentula, MD; Phone Number: +358 504270183; Email: panu.mentula@hus.fi

Study Locations

• Finland
  • Espoo, Finland
    • Recruiting
    • HUS, Jorvi Hospital
    • Contact: Hanna Lampela, MD
  • Helsinki, Finland, 00029
    • Recruiting
    • HUS, Meilahti Hospital
    • Contact: Panu J Mentula, MD
    • Contact: Panu Mentula, MD
    • Contact: Ville Sallinen, MD
    • Contact: Kirsi Lastunen, MD
  • Hyvinkää, Finland
    • Recruiting
    • HUS, Hyvinkää Hospital
    • Contact: Hanna Koppatz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Abdominal ultrasound and/or abdominal CT
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; Abdominal imaging is done selectively based on Adult Appendicitis Score
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; Observation based on Appendicitis Severity Score combined Adult Appendicitis Score based selective abdominal imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative appendectomy	Number of negative appendectomies (surgical removal of non-inflamed appendix)	Within 30 days from randomization
Complicated appendicitis	Number of patients with complicated appendicitis (AAST grade 3 or higher)	Within 30 days from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
histologically proven appendicitis	Number of patients with histologically proven appendicitis undergoing surgery	Within 30 days from randomization
CT scan	Number of patients having abdominal computed tomography	Within 30 days from randomization
Adverse events	Number patients with of adverse events (surgical complications, surgical site infections or delayed significant diagnosis)	Within one year from randomization
Appendicitis	Number of patients diagnosed with appendicitis	Within 2 years from randomization
Quality of life (EQ-5D-5L index value)	Quality of life determined by weekly EQ-5D-5L index values.	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.	During the first 30 days from randomization
Costs in Euros	Overall costs of diagnostics and treatment	During the first 30 days from randomization

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Panu Mentula, MD, Helsinki University Central Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: HUS/74/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No