NCT04519086

Brief Summary

This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to differentiate between uncomplicated and complicated acute appendicitis. Accurate differential diagnosis allows the assessment of all available treatment options. Complicated acute appendicitis requires emergency appendectomy, while uncomplicated acute appendicitis can be safely and efficiently treated with antibiotics in the majority of patients. Our study group already published the results of the initial OPTICAP trial enrolling patients with BMI under 30 showing similar accuracy between the low-dose and the stadard dose CT, but a significant dose reduction associated with the low-dose CT. All patients will undergo both imaging protocols as the standard CT is also optimized for a low as possible radiation dosage and imaging sequence per patient is randomized due to the optimization of contrast media injection timing. All patients participating in this study will be treated operatively with a laparoscopic appendectomy to obtain histological confirmation for the diagnosis to evaluate the accuracy of the CT imaging. The aim of this study is to optimize a well-performing low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis in patients with body mass index over 30 kg/m2.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

August 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

August 17, 2020

Last Update Submit

February 8, 2022

Conditions

AppendicitisOther and Unspecified Acute AppendicitisAcute DiseaseGastrointestinal DiseaseIntra-abdominal Infection

Keywords

low-dose computed tomographybody mass indexBMI > 30

Outcome Measures

Primary Outcomes (1)

  • The accuracy of low-dose vs. standard CT in diagnosing acute uncomplicated appendicitis in patients with BMI >30

    CT accuracy between low-dose and standard CT will be evaluated based on the operative and histopathological findings after laparoscopic appendectomy

    30 days

Secondary Outcomes (4)

  • Negative appendectomy rate

    30 days

  • Appendiceal perforation rate

    30 days

  • Sensitivity and specificity of the imaging protocols

    30 days

  • Radiation dose

    30 days

Study Arms (1)

Low-dose CT for acute appendicitis in patients with BMI >30

EXPERIMENTAL

Low-dose computed tomography (CT) vs. standard CT for diagnosing acute uncomplicated appendicitis in patients with BMI \> 30 Laparoscopic appendectomy

Radiation: Low-dose CTProcedure: Laparoscopic appendectomy

Interventions

Low-dose CTRADIATION

Low-dose computed tomography for suspected acute uncomplicated appendicitis in patients with BMI \>30

Low-dose CT for acute appendicitis in patients with BMI >30
Laparoscopic appendectomyPROCEDURE

All patients with BMI \>30, who are diagnosed with an uncomplicated acute appendicitis on low-dose CT-scan will undergo laparoscopic appendectomy to evaluate the sensitivity and specificity of the CT diagnosis

Low-dose CT for acute appendicitis in patients with BMI >30

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years
  • Clinical suspicion of acute uncomplicated appendicitis based on history, physical examination, laboratory findings evaluated by a senior surgeon
  • Body mass index over 30 kg/m2

You may not qualify if:

  • Age \<18 years or \> 60 years
  • Pregnancy or breastfeeding
  • Allergy to contrast material or iodine
  • History of appendectomy
  • Renal failure, creatinine-value greater than the upper reference value
  • Diabetes mellitus and metformin medication
  • Suspicion of peritonitis and appendiceal perforation
  • Incapability to cooperate and give consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University hospital

Turku, Southwest Finland, 20521, Finland

Location

MeSH Terms

Conditions

AppendicitisAcute DiseaseGastrointestinal DiseasesIntraabdominal Infections

Condition Hierarchy (Ancestors)

InfectionsGastroenteritisDigestive System DiseasesCecal DiseasesIntestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paulina Salminen, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 19, 2020

Study Start

November 4, 2020

Primary Completion

November 17, 2021

Study Completion

November 17, 2023

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Available from the study PI upon request.

Locations

FI(1)