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Trial record 2 of 2 for:    appendicitis | Singapore

Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis (RCTAppAlg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03324165
Recruitment Status : Active, not recruiting
First Posted : October 27, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
Sengkang Health
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Length of stay [ Time Frame: 2 weeks after discharge ]
    Duration of total hospitalization (measured in days) from point of admission to discharge.

  4. 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



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 21 to 80 who are admitted to Singapore General Hospital and Sengkang Health for suspected appendicitis based on admission diagnosis from the Emergency Department

Exclusion Criteria:

  • Patients who are pregnant
  • Patients below 21 or above 80 years of age
  • Patients with generalized peritonitis on presentation
  • Patients with palpable right iliac fossa mass on presentation
  • Patients with evidence of acute confusional state/dementia
  • Patients at high risk of surgery (ASA>4) from the study
  • Patients who are immunocompromised (on chemotherapy, steroids etc.)

Information from the National Library of Medicine

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


Locations
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Singapore
Sengkang Health
Singapore, Singapore, 159964
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
National Medical Research Council (NMRC), Singapore
Sengkang Health
Investigators
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Principal Investigator: Tan Jianhong Winson, MBBS Singapore General Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03324165    
Other Study ID Numbers: CIRB 2015/2981
NMRC/HSRNIG/0012/2015 ( Other Grant/Funding Number: National Medical Research Council (NMRC), Singapore )
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Computed Tomography
Algorithm
Alvarado Score
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases