NCT06083064

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Nov 2023Dec 2028

First Submitted

Initial submission to the registry

October 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

October 5, 2023

Last Update Submit

March 10, 2025

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • histologically proven appendicitis

    Within 30 days from randomization

  • CT scan

    Within 30 days from randomization

  • Adverse events

    Within one year from randomization

  • Appendicitis

    Within 2 years from randomization

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

    During the first 30 days from randomization

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: Score based selective observation combined with selective abdominal imaging

Interventions

Abdominal imagingDIAGNOSTIC_TEST

Abdominal ultrasound and/or abdominal CT

Routine imaging
Score based selective abdominal imagingOTHER

Abdominal imaging is done selectively based on Adult Appendicitis Score

Adult Appendicitis Score based selective imaging
Score based selective observation combined with selective abdominal imagingOTHER

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Suspicion of appendicitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HUS, Jorvi Hospital

Espoo, Finland

RECRUITING

HUS, Meilahti Hospital

Helsinki, 00029, Finland

RECRUITING

HUS, Hyvinkää Hospital

Hyvinkää, Finland

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24970111BACKGROUND

  • 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.

    PMID: 35482016BACKGROUND

  • 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.

    PMID: 25963411BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Panu Mentula, MD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Panu Mentula, MD

CONTACT

504270183panu.mentula@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 1:1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 13, 2023

Study Start

November 15, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(3)