Is Acute Appendicitis Still a Clinical Diagnosis?

Appendicitis Clinical Trial

Official title:

Is Acute Appendicitis Still a Clinical Diagnosis? Use of Preoperative Diagnostic Imaging Before Appendectomy in Denmark During 2000-15.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477824
• Other study ID #: APP-DIM
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: January 31, 2016

Study information

• Verified date: September 2020
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the use of preoperative diagnostic imaging before appendectomy in Denmark and whether it has changed over time during the period from 2000-15. Secondly, the study aims to investigate regional, age and gender differences in the same setting.

Description:

Acute appendicitis is the most common cause of abdominal pain (1) and appendectomy is the most common emergency surgical procedure performed worldwide (2). During the last decades, there has been a paradigm shift in both diagnosis and treatment of appendicitis - surgical treatment has changed from open to laparoscopic appendectomy (3). Acute appendicitis has traditionally been a clinical diagnosis, but the use of preoperative diagnostic imaging has, in some countries, increased dramatically (4). The use of computed tomography (CT) before appendectomy is in the United States up to 90%, in England 13% and in Holland almost all patients undergo ultrasound and/or CT before appendectomy (1).

The use of antibiotics can be successful in the treatment of uncomplicated appendicitis verified on CT, and the use of CT has significantly lowered the negative appendectomy rate compared to clinical evaluation only (1). But the use of CT is inevitably inducing radiation and increasing lifetime risk of cancer - especially in younger patients who most frequently present with acute appendicitis (1,5). It is estimated that CT of the abdominal region can avoid 12 negative appendectomies but at the cost of one cancer death due to radiation (5). In Denmark surgery is still the only treatment for appendicitis, but how is appendicitis diagnosed? Is acute appendicitis still a clinical diagnosis?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82000
• Est. completion date: January 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis for appendicitis undergoing appendectomy during the same admission during the period 2000-15

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Appendicitis

Intervention

Diagnostic Test:
• Diagnostic imaging
Ultrasonography, computerized tomography, magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Claus Anders Bertelsen, PhD, MD

References & Publications (10)

Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016. Review. — View Citation

GlobalSurg Collaborative. Mortality of emergency abdominal surgery in high-, middle- and low-income countries. Br J Surg. 2016 Jul;103(8):971-988. doi: 10.1002/bjs.10151. Epub 2016 May 4. Erratum in: Br J Surg. 2017 Apr;104(5):632. — View Citation

Kleif J, Thygesen LC, Gögenur I. Validity of the diagnosis of appendicitis in the Danish National Patient Register. Scand J Public Health. 2020 Feb;48(1):38-42. doi: 10.1177/1403494818761765. Epub 2018 Mar 19. — View Citation

Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011 Jul;39(7 Suppl):30-3. doi: 10.1177/1403494811401482. — View Citation

Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965. — View Citation

Raja AS, Wright C, Sodickson AD, Zane RD, Schiff GD, Hanson R, Baeyens PF, Khorasani R. Negative appendectomy rate in the era of CT: an 18-year perspective. Radiology. 2010 Aug;256(2):460-5. doi: 10.1148/radiol.10091570. Epub 2010 Jun 7. — View Citation

Rogers W, Hoffman J, Noori N. Harms of CT scanning prior to surgery for suspected appendicitis. Evid Based Med. 2015 Feb;20(1):3-4. doi: 10.1136/ebmed-2014-110075. Epub 2014 Nov 27. — View Citation

Rud B, Vejborg TS, Rappeport ED, Reitsma JB, Wille-Jørgensen P. Computed tomography for diagnosis of acute appendicitis in adults. Cochrane Database Syst Rev. 2019 Nov 19;2019(11). doi: 10.1002/14651858.CD009977.pub2. — View Citation

Sallinen V, Akl EA, You JJ, Agarwal A, Shoucair S, Vandvik PO, Agoritsas T, Heels-Ansdell D, Guyatt GH, Tikkinen KA. Meta-analysis of antibiotics versus appendicectomy for non-perforated acute appendicitis. Br J Surg. 2016 May;103(6):656-667. doi: 10.1002/bjs.10147. Epub 2016 Mar 17. Review. — View Citation

von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual percentage use diagnostic imaging before appendectomy	Annual percentage use of abdominal ultrasonography, abdominal computerized tomography (with or without contrast) and abdominal MRI 24 hours before appendectomy for appendicitis.	24 hours
Secondary	Differences in use of ultrasonography.	Differences in use of ultrasonography between gender, age groups divided into decades and the five Danish administrative regions.	24 hours
Secondary	Differences in use of abdominal computerized tomography (with or without contrast)	Differences in use of abdominal computerized tomography (with or without contrast) between gender, age groups divided into decades and the five Danish administrative regions.	24 hours
Secondary	Differences in use of magnetic resonance imaging	Differences in use of magnetic resonance imaging between gender, age groups divided into decades and the five Danish administrative regions.	24 hours

External Links

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