Clinical trial NCT06000020: Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study
Official title: Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Appendicitis Acute
Keywords: Laparoscopic appendectomy
Normal findings
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing diagnostic laparoscopy on suspicion of acute appendicitis

Brief summary: Based on a regional cohort, this study we will try to demonstrate the superiority of routine laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in cases of normal findings at diagnostic laparoscopy. If routine laparoscopic appendectomy is not superior, we will recommend leaving the "normal" appendix in situ.

Detailed description: The study is a retrospective cohort study with a superiority design. It will be carried out at the surgical departments of the four public university hospitals providing emergency surgical service to the entire population of 1,8 million in the Capital Region of Denmark.

On March 17, 2017, a new electronic health record (EHR) had been implemented at three of the hospital, while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20, 2017. These dates mark the start of the inclusion period for each hospital, while the inclusion period ended April 1, 2021 for all four hospitals.

The "snap boards" covering the relevant operation rooms at the four hospitals will be systematically review. For all cases, where diagnostic laparoscopy was performed on suspicion of acute appendicitis, the EHR will be reviewed.

Eligibility criteria: Inclusion Criteria:

* Diagnostic laparoscopy with normal intraoperative findings (including mesenteric adenitis
* Laparoscopic appendectomy and a histopathological normal appendix and otherwise normal intraoperative findings (including mesenteric adenitis)

Exclusion Criteria:

* Diagnostic laparoscopy with abnormal intraoperative findings.
* Laparoscopic appendectomy and a histopathological non-normal appendix.
* Laparoscopic appendectomy and a histopathological normal appendix and abnormal intraoperative findings.

Primary outcomes:
measure: Risk of surgery on suspicion of acute appendicitis
timeFrame: 3 years
measure: Risk of surgery on suspicion of acute appendicitis
timeFrame: 5 years
Secondary outcomes:
measure: Reintervention
timeFrame: 30 days
measure: Postoperative complications
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Copenhagen University Hospital - Bispebjerg
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital - North Zealand
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital - Hvidovre
Study officials:
affiliation: cabertelsen@gmail.com
name: Claus A Bertelsen, Ph.D.
role: STUDY_CHAIR
References:
citation: Jaunoo SS, Hale AL, Masters JP, Jaunoo SR. An international survey of opinion regarding investigation of possible appendicitis and laparoscopic management of a macroscopically normal appendix. Ann R Coll Surg Engl. 2012 Oct;94(7):476-80. doi: 10.1308/003588412X13373405385377.
citation: 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.
citation: Bakker OJ, Go PM, Puylaert JB, Kazemier G, Heij HA; Werkgroep richtlijn Diagnostiek en behandeling van acute appendicitis. [Guideline on diagnosis and treatment of acute appendicitis: imaging prior to appendectomy is recommended]. Ned Tijdschr Geneeskd. 2010;154:A303. Dutch.
citation: Lee M, Paavana T, Mazari F, Wilson TR. The morbidity of negative appendicectomy. Ann R Coll Surg Engl. 2014 Oct;96(7):517-20. doi: 10.1308/003588414X13946184903801.
citation: Bijnen CL, Van Den Broek WT, Bijnen AB, De Ruiter P, Gouma DJ. Implications of removing a normal appendix. Dig Surg. 2003;20(2):115-21. doi: 10.1159/000069386.
citation: Gough IR, Morris MI, Pertnikovs EI, Murray MR, Smith MB, Bestmann MS. Consequences of removal of a "normal" appendix. Med J Aust. 1983 Apr 16;1(8):370-2. doi: 10.5694/j.1326-5377.1983.tb99414.x.
citation: Sorensen AK, Bang-Nielsen A, Levic-Souzani K, Pommergaard HC, Jorgensen AB, Tolstrup MB, Rud B, Kovacevic B, Bulut O. Readmission and reoperation rates following negative diagnostic laparoscopy for clinically suspected appendicitis: The "normal" appendix should not be removed - A retrospective cohort study. Int J Surg. 2019 Apr;64:1-4. doi: 10.1016/j.ijsu.2019.02.001. Epub 2019 Feb 12.