Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
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| ClinicalTrials.gov Identifier: NCT03522233 |
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Recruitment Status : Unknown
Verified April 2018 by Children's Hospitals and Clinics of Minnesota.
Recruitment status was: Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
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| Condition or disease |
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| Appendicitis |
Background Acute appendicitis (AA) is the most common condition requiring emergency surgery in children. The potential for morbidity and mortality from perforation of the appendix necessitates prompt diagnosis.2 Acute appendicitis scoring systems such as pediatric appendicitis score (PAS) use elements of history, exam findings, and lab tests to identify patients at high risk of having acute appendicitis.3 Despite having limited use for this intent 4,5 these scores are often used to stratify patients by risk for continued observation, imaging or operative care. 6 While CT scans may have higher diagnostic yield, its use is not without risk. CT- related radiation exposure has been shown to increase cancer risk. There have been US first strategies published by the American College of Radiology7 and the American College of Emergency Physicians.8 However, nearly 50% of appendix US examinations are equivocal, which poses a dilemma for EM physicians and results in variation in clinical care.
Various strategies exist for the diagnostic approach to the patient after equivocal US with symptoms of AA. While select patients may be safely discharged based on clinical judgment,9 emergency providers often obtain CT or admit patients for clinical observation. In a study conducted by Garcia et al., they concluded that a protocol of US followed by CT in children with negative or equivocal US exam results in beneficial management as well as cost savings.10 In a study by Gregory et al., they concluded that a clinical decision rule followed by staged imaging was found to be the most cost-effective approach for diagnosis of AA in children.11 Bachur et al. integrated PAS score with US findings and concluded that patients with high risk (PAS 7-10) but negative US or low risk (PAS 0-3) benefit from serial exam or further work up. 12 The addition of US to the strategy reduced CT utilization.11 Standardized radiology reports have also been shown to reduce CT scans and admissions for observation.13 At a network of institutions nationwide a tool called the pediatric appendicitis risk calculator (pARC)1 is being studied to assess patient's true risk of appendicitis and provide guidance for clinical management to ER physicians. Preliminary studies have found the pARC to be more accurate at predicting risk of appendicitis in children when compared to PAS score.
The study objective is to assess acute care charges and clinical outcomes among children with appendix US and pARC < 25%. To the investigator's knowledge, this is the first study to do so in a tertiary care pediatric hospital.
| Study Type : | Observational |
| Estimated Enrollment : | 800 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Clinical Outcomes and Charges After Risk Stratification by Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds at a Tertiary Care Pediatric Hospital |
| Actual Study Start Date : | September 23, 2017 |
| Estimated Primary Completion Date : | October 1, 2018 |
| Estimated Study Completion Date : | October 1, 2019 |
- Rate of Equivocal Appendix Ultrasound [ Time Frame: September 2017-October 2018 ]To determine the rate of equivocal appendix US among children with pARC <25%.
- Rate of Appendicitis [ Time Frame: September 2017-October 2018 ]To determine rate of appendicitis among children with pARC <25% who had an appendix ultrasound.
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| Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients between 5-18 years
- Patients who had an appendix ultrasound in one of our EDs
Exclusion Criteria:
- Outside appendix ultrasound or abdominal CT obtained
- Previous significant abdominal surgery (for example appendectomy, short gut, ileostomy, Hirschsprungs with pull through)
- No CBC obtained (i.e. cannot determine pARC)
- Developmental or cognitive delay that impedes communication
- If there is suspected abuse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522233
| Contact: Brianna S McMichael, MPH | 612-813-7104 | Brianna.McMichael@Childrensmn.org | |
| Contact: Heidi Vander Velden, MS | (612) 813-7892 | heidi.vandervelden@childrensmn.org |
| United States, Minnesota | |
| Children's Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Brianna McMichael, MPH | |
| Children's Minnesota | Recruiting |
| Saint Paul, Minnesota, United States, 55102 | |
| Contact: Brianna McMichael, MPH | |
| Principal Investigator: | Callie Becker, MD | Children's Minnesota |
| Responsible Party: | Children's Hospitals and Clinics of Minnesota |
| ClinicalTrials.gov Identifier: | NCT03522233 |
| Other Study ID Numbers: |
1708-113 |
| First Posted: | May 11, 2018 Key Record Dates |
| Last Update Posted: | May 11, 2018 |
| Last Verified: | April 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Appendicitis Intraabdominal Infections Infections Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Cecal Diseases Intestinal Diseases |