Impact of Oral Contrast in the Large Intestine on the Recognition of Appendix

NCT02497183 | Terminated DMC

• 1 other identifier: 0053-15-EMC
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Acute appendicitis is the most common cause of abdominal pain requiring surgical intervention. The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its effectiveness, the test involves exposure to a high dose of radiation. Using ultrasound to diagnose this condition has been described extensively in the medical literature, and this test has a very high specificity (over 95%), however sensitivity of the test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test include operator dependency as well as factors such as body habitus of the patient, presence of technical disturbances (artifacts) caused by gas in the large intestine and inadequate cooperation from the patient during the exam. All of these factors may affect the ability to detect sonographic signs of appendicitis. The investigators believe that it is possible to reduce the amount of artifacts caused by the presence of gas in the intestine by filling of the colon with liquid suspension that is routinely given in the investigators' hospital before performing an abdominal CT and performing an additional ultrasound scan to those patients in which the initial ultrasound examination (without any preparation) proved to be equivocal or not diagnostic. The target population for the study is any patient who arrives to the emergency room with complaints of right lower quadrant abdominal pain and it is decided by the referring physician in the ER to start diagnostic workup for suspected appendicitis by performing an ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided that the patient needs to continue investigation by performing a CT scan, the patient will receive contrast material orally for approximately 180 minutes and prior to the CT the investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat ultrasound will allow a statistically significant improvement in the detection rate of the appendix.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• statistically significant improvement in the detection rate of the appendix

  ultrasound exam with filling of the colon with liquid suspension will allow a statistically significant improvement in the detection rate of the appendix compared to an exam without any preparation.

  one year

Study Arms (1)

first

EXPERIMENTAL

a repeat abdominal ultrasound exam to patients following the filling of bowel with contrast material per os.

Device: ultrasound; Other: iodine based solution of oral contrast material

Interventions

ultrasound DEVICE

A repeat ultrasound exam following oral contrast material consumption

first

iodine based solution of oral contrast material OTHER

A solution of oral contrast material that is routinely used in our institution prior to performing a computed tomographic (CT) examinations of the gastrointestinal tract will be given prior to performing the repeat ultrasound/

Also known as: Telebrix Gastro

first

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age 14 years to 120 years
• patients that underwent an ultrasound exam that proved to be equivocal or not diagnostic
• patients who were sent to perform a CT scan that includes drinking oral contrast material.

You may not qualify if:

• pregnant patients
• patients with known allergy to oral contrast material (TELEBRIX gastro)

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek medical center

Afula, Israel

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Leonid Roshkovan, M.D

  haemek medical center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

IL (1)