NCT04477824

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

16 years

First QC Date

July 15, 2020

Last Update Submit

September 8, 2020

Conditions

Keywords

AppendicitisAppendectomyPreoperative diagnostic imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Differences in use of ultrasonography.

    24 hours

  • Differences in use of abdominal computerized tomography (with or without contrast)

    24 hours

  • Differences in use of magnetic resonance imaging

    24 hours

Interventions

Diagnostic imagingDIAGNOSTIC_TEST

Ultrasonography, computerized tomography, magnetic resonance imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in Denmark with a diagnosis for appendicitis undergoing appendectomy during the same admission during the period 2000-15

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

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

    PMID: 31743429BACKGROUND
  • 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.

    PMID: 27145169BACKGROUND
  • 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.

    PMID: 27437029BACKGROUND
  • 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.

    PMID: 20529988BACKGROUND
  • 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.

    PMID: 25429870BACKGROUND
  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche 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.

    PMID: 25046131BACKGROUND
  • 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.

    PMID: 21775347BACKGROUND
  • Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965.

    PMID: 21775345BACKGROUND
  • Kleif J, Thygesen LC, Gogenur 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.

    PMID: 29554842BACKGROUND
  • 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.

    PMID: 26990957BACKGROUND

Related Links

MeSH Terms

Conditions

Appendicitis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Claus A Bertelsen, Phd

    Nordsjaellands Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, consultant surgeon

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

January 1, 2000

Primary Completion

December 31, 2015

Study Completion

January 31, 2016

Last Updated

September 9, 2020

Record last verified: 2020-09