Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis (RCTAppAlg)
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|ClinicalTrials.gov Identifier: NCT03324165|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2017
Last Update Posted : September 6, 2018
Acute appendicitis is one of the most common causes of acute abdominal pain requiring surgical intervention. In the current era, with diagnostic imaging technique like Computed Tomography (CT), negative appendectomy rates have been greatly reduced. However, the radiation risk with CT poses as a concern. Rules for clinical decision guiding CT utilization is thus essential to minimize unnecessary CT scans, which not only poses a radiation risk but also contributes to increased healthcare costs.
Through the development of an algorithm based on Alvarado Score for the management of acute appendicitis, investigators hope to reduce CT utilization with an acceptable negative appendectomy rate, and hence reducing unnecessary radiation and the healthcare costs involved.
|Condition or disease||Intervention/treatment||Phase|
|Acute Appendicitis||Other: Proposed Algorithm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Randomized Control Trial Comparing Proposed Algorithm and Current Best Practice in the Evaluation of Suspected Appendicitis|
|Actual Study Start Date :||October 1, 2016|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
No Intervention: Usual Care Arm
Patients randomized to Usual Care Arm will be managed as per current best practice that is based on the individual doctor's discretion.
Experimental: Intervention Arm
Patients randomized to Intervention Arm will be managed as per the proposed algorithm, which is based on the computation of Alvarado Score.
Other: Proposed Algorithm
Proposed algorithm that uses Alvarado Score to guide CT utilization
- Percentage of CT performed [ Time Frame: Through study completion, an average of 2 years. ]The percentage of CT scans performed for patients within each management arm
- Percentage of negative appendectomy [ Time Frame: Through study completion, an average of 2 years. ]Patients who were operated with a pre-operative diagnosis of acute appendicitis with subsequent histology showing no features of acute appendicitis
- Percentage of missed diagnosis [ Time Frame: 2 weeks after discharge ]Patients who were not diagnosed with acute appendicitis during the initial admission but were subsequently readmitted within 2 weeks of discharge due to progression of symptoms, with eventual surgery showing acute appendicitis on histology.
- Length of stay [ Time Frame: 2 weeks after discharge ]Duration of total hospitalization (measured in days) from point of admission to discharge.
- Cost of stay [ Time Frame: 2 weeks after discharge ]Total cost of stay incurred by the patient in Singapore Dollars during admission before government subsidies were taken into consideration
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): NCT03324165
|Singapore, Singapore, 159964|
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Tan Jianhong Winson, MBBS||Singapore General Hospital|