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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1:1

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Abdominal imaging

Intervention Type DIAGNOSTIC_TEST

Abdominal ultrasound and/or abdominal CT

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.

Group Type EXPERIMENTAL

Score based selective abdominal imaging

Intervention Type OTHER

Abdominal imaging is done selectively based on Adult Appendicitis Score

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.

Group Type EXPERIMENTAL

Score based selective observation combined with selective abdominal imaging

Intervention Type OTHER

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

Interventions

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Abdominal imaging

Abdominal ultrasound and/or abdominal CT

Intervention Type DIAGNOSTIC_TEST

Score based selective abdominal imaging

Abdominal imaging is done selectively based on Adult Appendicitis Score

Intervention Type OTHER

Score based selective observation combined with selective abdominal imaging

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No