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

NCT03324165 | Unknown DMC

• 2 other identifiers: CIRB 2015/2981NMRC/HSRNIG/0012/2015
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Appendicitis

Keywords

Computed Tomography; Algorithm; Alvarado Score

Outcome Measures

Primary Outcomes (1)

• Percentage of CT performed

  The percentage of CT scans performed for patients within each management arm

  Through study completion, an average of 2 years.

Secondary Outcomes (4)

• Percentage of negative appendectomy

  Through study completion, an average of 2 years.

• Percentage of missed diagnosis

  2 weeks after discharge

• Length of stay

  2 weeks after discharge

• Cost of stay

  2 weeks after discharge

Study Arms (2)

Usual Care Arm

NO INTERVENTION

Patients randomized to Usual Care Arm will be managed as per current best practice that is based on the individual doctor's discretion.

Intervention Arm

EXPERIMENTAL

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

Interventions

Proposed Algorithm OTHER

Proposed algorithm that uses Alvarado Score to guide CT utilization

Intervention Arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• Sengkang Health: collaborator

Study Sites (2)

Sengkang Health

Singapore, 159964, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (13)

• Birnbaum BA, Wilson SR. Appendicitis at the millennium. Radiology. 2000 May;215(2):337-48. doi: 10.1148/radiology.215.2.r00ma24337.

  PMID: 10796905 BACKGROUND

• Rothrock SG, Pagane J. Acute appendicitis in children: emergency department diagnosis and management. Ann Emerg Med. 2000 Jul;36(1):39-51. doi: 10.1067/mem.2000.105658.

  PMID: 10874234 BACKGROUND

• Yildirim E, Karagulle E, Kirbas I, Turk E, Hasdogan B, Teksam M, Coskun M. Alvarado scores and pain onset in relation to multislice CT findings in acute appendicitis. Diagn Interv Radiol. 2008 Mar;14(1):14-8.

  PMID: 18306139 BACKGROUND

• Hong JJ, Cohn SM, Ekeh AP, Newman M, Salama M, Leblang SD; Miami Appendicitis Group. A prospective randomized study of clinical assessment versus computed tomography for the diagnosis of acute appendicitis. Surg Infect (Larchmt). 2003 Fall;4(3):231-9. doi: 10.1089/109629603322419562.

  PMID: 14588157 BACKGROUND

• Jones K, Pena AA, Dunn EL, Nadalo L, Mangram AJ. Are negative appendectomies still acceptable? Am J Surg. 2004 Dec;188(6):748-54. doi: 10.1016/j.amjsurg.2004.08.044.

  PMID: 15619494 BACKGROUND

• Smink DS, Finkelstein JA, Garcia Pena BM, Shannon MW, Taylor GA, Fishman SJ. Diagnosis of acute appendicitis in children using a clinical practice guideline. J Pediatr Surg. 2004 Mar;39(3):458-63; discussion 458-63. doi: 10.1016/j.jpedsurg.2003.11.015.

  PMID: 15017570 BACKGROUND

• Berrington de Gonzalez A, Darby S. Risk of cancer from diagnostic X-rays: estimates for the UK and 14 other countries. Lancet. 2004 Jan 31;363(9406):345-51. doi: 10.1016/S0140-6736(04)15433-0.

  PMID: 15070562 BACKGROUND

• Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

  PMID: 18046031 BACKGROUND

• Brenner DJ. Minimising medically unwarranted computed tomography scans. Ann ICRP. 2012 Oct-Dec;41(3-4):161-9. doi: 10.1016/j.icrp.2012.06.004. Epub 2012 Aug 22.

  PMID: 23089015 BACKGROUND

• Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.

  PMID: 3963537 BACKGROUND

• National Research Council (US) Board on Radiation Effects Research. Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII, Phase I, Letter Report (1998). Washington (DC): National Academies Press (US); 1998. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK224187/

  PMID: 25077203 BACKGROUND

• Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451.

  PMID: 18566177 BACKGROUND

• Tan WJ, Acharyya S, Chew MH, Foo FJ, Chan WH, Wong WK, Ooi LL, Ng JCF, Ong HS. Randomized control trial comparing an Alvarado Score-based management algorithm and current best practice in the evaluation of suspected appendicitis. World J Emerg Surg. 2020 May 1;15(1):30. doi: 10.1186/s13017-020-00309-0.

  PMID: 32357897 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Tan Jianhong Winson, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 27, 2017
• Study Start: October 1, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)