Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study

Appendicitis Acute Clinical Trial

Official title:

Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06000020
• Other study ID #: LapApp
• Status: Active, not recruiting
• Start date: March 17, 2017
• Est. completion date: April 1, 2026

Study information

• Verified date: August 2023
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1400
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

Procedure:
• Laparoscopic appendectomy
Laparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital - Bispebjerg	Copenhagen NV
Denmark	Copenhagen University Hospital - Herlev	Herlev
Denmark	Copenhagen University Hospital - North Zealand	Hillerød
Denmark	Copenhagen University Hospital - Hvidovre	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Int J Surg. 2020 Jul;79:154. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of surgery on suspicion of acute appendicitis	Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis	3 years
Primary	Risk of surgery on suspicion of acute appendicitis	Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis	5 years
Secondary	Reintervention	Laparoscopy or laparotomy due to complications	30 days
Secondary	Postoperative complications	Postoperative complications according to the 'Clavien-Dindo classification'	30 days
Secondary	Length of stay	Time from index surgery to discharge	30 days