Limited Abdominal CT in ED Patients With Abdominal Pain
Limited Abdominal CT in ED Patients With Abdominal Pain
The purpose of the study is to compare the diagnosis and management (treatment and
 disposition) of adult emergency department patients with acute nontraumatic abdominal pain
 and tenderness, based on two CT techniques:

 1. Standard (complete) abdominal-pelvic CT. The American College of Radiology calls for the
 cephalad limit of abdominal CT to begin at the dome of the diaphragm, and the caudad
 limit of pelvic CT to extend through the ischial tuberosities.

 2. A z-axis restricted subset of images digitally obtained from the original CT dataset,
 determined by the region of tenderness identified by the examining emergency physician
 and marked on the patient prior to the performance of the CT. This z-axis restricted CT
 does not require any additional radiation exposure to the patient, as it will be
 produced by computer extraction of data from the original standard abdominal-pelvic CT.

 The investigators hypothesize that the diagnosis and management will not differ when guided
 by the two CT scan interpretations. Radiation doses will be calculated for each of the two
 techniques.
This will be a prospective study with informed consent from patient subjects.

 Informed consent will be obtained prior to subject enrollment. The study protocol requires
 the following steps to be performed, each of which is described in more detail later in this
 document:

 1. Potential patient subject is identified by research staff, by virtue of abdominal-pelvic
 CT being ordered for clinical evaluation of nontraumatic abdominal pain and tenderness,
 as determined by a board-certified attending emergency physician.

 2. Research staff applies inclusion and exclusion criteria to confirm patient eligibility.

 3. Potential subjects who fail one or more inclusion or meet one or more exclusion criteria
 are recorded in electronic research log with reason for exclusion but are not asked to
 participate in study. Recorded information includes age (if greater than 89, will simply
 be recorded as "greater than 89"), gender, race/ethnicity, date, and reason for
 exclusion. No identifiers are recorded for these patients. The purpose of this
 information is to allow comparison of the enrolled group with all patients with
 abdominal pain undergoing CT. This will be part of a CONSORT flow diagram, allowing
 readers to understand potential selection bias and to understand the probable clinical
 population in the context of all emergency department's (ED) patients undergoing
 abdominal CT.

 4. Eligible potential subjects (meeting all inclusion and no exclusion criteria) are asked
 to participate in study with informed consent. The study will be introduced to potential
 subjects by the emergency physician caring for this patient. The study will be
 introduced only after CT for evaluation of abdominal pain and tenderness is ordered by
 the physicians caring for the patient, as this is a study inclusion criterion. Potential
 subjects who do not give informed consent to participate are recorded in electronic
 research log but not enrolled in study. No identifiers are recorded for these patients.
 Recorded information includes age (if greater than 89, will simply be recorded as
 "greater than 89"), gender, race/ethnicity, date, and reason for exclusion. No
 identifiers are recorded for these patients.

 5. Patients who give informed consent are enrolled in study as subjects.

 6. Attending board-certified emergency physician places skin surface markers delineating
 region of abdominal tenderness, using an examination technique described below. Patient
 is marked with stickers while in supine position with arms above head, as required for
 CT. Attending board-certified emergency physician also places additional markers to
 blind radiological interpretation with respect to actual area of tenderness. Attending
 board-certified emergency physician is also asked to report the working diagnosis,
 treatment and disposition plan prior to CT scan being performed. An electronic
 standardized reporting form will be used. Reporting forms are designed in a format of
 electronic surveys and will be stored on password-protected server, designed
 specifically for research purposes. The information to be collected will be the same as
 the information in the attached appendices.

 7. Patient undergoes CT scan of complete abdomen and pelvis following usual institutional
 protocol, concordant with American College of Radiology standard.1

 8. Images corresponding to the region of tenderness (z-axis restricted) are loaded onto a
 server. A board-certified attending radiologist blinded to the remaining CT images
 interprets the z-axis limited CT images and generates an electronic report, using a
 standardized research reporting system. The report is electronically time-stamped and
 cannot be altered.

 9. The attending board-certified emergency physician is immediately provided with the
 electronic CT report from the z-axis limited CT. That physician immediately completes a
 standardized electronic research reporting form, indicating the current clinical
 diagnosis, treatment plan, and disposition. The form is electronically time-stamped and
 cannot be altered.

 10. The board-certified attending radiologist who interpreted the z-axis restricted CT is
 then immediately contacted and interprets the complete CT, including all available
 images. A report is generated using similar standardized electronic research reporting
 system used for the z-axis restricted CT. The report is electronically time-stamped and
 cannot be altered.

 11. The attending board-certified emergency physician is immediately provided with the CT
 report from the complete CT. That physician immediately completes an electronic
 standardized research reporting form, indicating the current clinical diagnosis,
 treatment plan, and disposition. The form is electronically time-stamped and cannot be
 altered.

 12. Patient care then proceeds according to the usual clinical standard in the institution.

 13. Subject records are reviewed to determine final diagnosis and treatment.
Inclusion Criteria:

 -  emergency department's patients undergoing CT evaluation for acute abdominal pain and
 tenderness (acute is defined as onset of current episode within 7 days of emergency
 department presentation).

 Exclusion Criteria:

 -  neurological disorders

 -  altered mental status

 -  history of intra-abdominal surgery in the past 30 days

 -  BMI higher than 35

 -  immunocompromised patients

 -  abdominal trauma in the past 30 days

 -  CT is ordered for the following indications:

 -  isolated vomiting

 -  fever without source

 -  staging of malignancy

 -  isolated flank pain or suspected renal colic