The Optimization of a Low-dose Computed Tomography Protocol in Patients With Suspected Uncomplicated Acute Appendicitis

NCT02533869 | Completed

• 1 other identifier: OPTICAP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. Differentiation between the two forms of acute appendicitis is important because according to recent studies their treatment differs. Complicated forms are still treated operatively, while uncomplicated forms can be treated conservatively with antibiotics. In the initial phase of the study, several optimized CT protocols will be created with a phantom model. The two best performing models will be selected for the second phase of the study, in which patients presenting with suspected acute appendicitis will be imaged with the two protocols. All patients participating in the study will be treated operatively, primarily with a laparoscopic appendectomy. Thus histological confirmation for the diagnosis can be achieved and compared with the CT images. The goal of this study is to optimize a well-performing low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis.

Conditions

Appendicitis; Other and Unspecified Acute Appendicitis; Acute Disease; Gastrointestinal Diseases; Intra-abdominal Infection

Keywords

low-dose computed tomography

Outcome Measures

Primary Outcomes (1)

• The specificity and sensitivity of low-dose CT in diagnosing acute uncomplicated appendicitis

  The sensitivity and specificity will be evaluated based on the operative and histopathological findings after laparoscopic appendectomy

  Four months

Secondary Outcomes (2)

• Negative appendectomy rate

  Six months

• Appendiceal perforation rate

  Six months

Study Arms (1)

Low-dose CT for acute appendicitis

EXPERIMENTAL

Low-dose computed tomography for diagnosing acute uncomplicated appendicitis Laparoscopic appendectomy

Radiation: Low-dose CT; Procedure: Laparoscopic appendectomy

Interventions

Low-dose CT RADIATION

Low-dose computed tomography for suspected acute uncomplicated appendicitis

Low-dose CT for acute appendicitis

Laparoscopic appendectomy PROCEDURE

All patients 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

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
• A severe generalized disease or condition

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Appendicitis; Acute Disease; Gastrointestinal Diseases; Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections; Gastroenteritis; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological 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 18, 2015
• First Posted: August 27, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

FI (1)