Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT

NCT00913380 | Completed Phase 3 Results

• 1 other identifier: SNUBH-LDCTinAPPY
• Study Type: interventional
• Target: 891
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Negative Appendectomy

  Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)

  1 week after surgery

Secondary Outcomes (9)

• Additional Imaging Test(s)

  1 week after CT

• Appendiceal Perforation

  1 week after surgery

• Interval Between CT and Appendectomy

  1 day after surgery

• Interval Between CT and Discharge Without Surgery

  3 months after CT

• Interval From CT to Discharge After Appendectomy

  3 months after CT

Other Outcomes (2)

• Radiation Dose

  1 day after CT

• Estimate of Carcinogenic Risk Induced by CT Radiation

  1 day after CT

Study Arms (2)

Low-dose CT

EXPERIMENTAL

Radiation: Diagnostic CT

Standard-dose CT

ACTIVE COMPARATOR

Radiation: Diagnostic CT

Interventions

Diagnostic CT RADIATION

2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))

Also known as: low-dose CT

Low-dose CT

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Suspected of having acute appendicitis
• Referred for abdomen CT from Emergency Department

You may not qualify if:

• Body mass index \< 18.5 kg/m2 (ultrasonography is favored)
• Intravenous contrast-enhancement is contraindicated

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• GE Healthcare: collaborator
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• Kim K, Kim YH, Kim SY, Kim S, Lee YJ, Kim KP, Lee HS, Ahn S, Kim T, Hwang SS, Song KJ, Kang SB, Kim DW, Park SH, Lee KH. Low-dose abdominal CT for evaluating suspected appendicitis. N Engl J Med. 2012 Apr 26;366(17):1596-605. doi: 10.1056/NEJMoa1110734.

  PMID: 22533576 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

In this diagnostic trial, participants have a variety of abdominal diseases. Events with CTCAE v4 Grade 2 or less are not considered reportable according to the Study Protocol.

Results Point of Contact

• Title: Kyoung Ho Lee
• Organization: Seoul National University Bundang Hospital

kholeemail@gmail.com

82-31-787-7607

Study Officials

• Kyoung Ho Lee, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Kyuseok Kim, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: June 4, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 12, 2011
• Results First Posted: September 2, 2011

Record last verified: 2011-09

Locations

KR (1)