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

NCT06000020 | Active Not Recruiting

• 1 other identifier: LapApp
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 4

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.

Conditions

Appendicitis Acute

Keywords

Laparoscopic appendectomy; Normal findings

Outcome Measures

Primary Outcomes (2)

• Risk of surgery on suspicion of acute appendicitis

  Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis

  3 years

• Risk of surgery on suspicion of acute appendicitis

  Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis

  5 years

Secondary Outcomes (3)

• Reintervention

  30 days

• Postoperative complications

  30 days

• Length of stay

  30 days

Study Arms (2)

Diagnostic laparoscopy

Diagnostic laparoscopy on suspicion of acute appendicitis with normal intraoperative findings (including mesenteric adenitis).

Laparoscopic appendectomy

Laparoscopic appendectomy despite normal intraoperative findings (including mesenteric adenitis) and histopathology showing a normal appendix.

Procedure: Laparoscopic appendectomy

Interventions

Laparoscopic appendectomy PROCEDURE

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

Laparoscopic appendectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing diagnostic laparoscopy on suspicion of acute appendicitis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (4)

Copenhagen University Hospital - Bispebjerg

Copenhagen NV, 2400, Denmark

Location

Copenhagen University Hospital - Herlev

Herlev, 2730, Denmark

Location

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

Copenhagen University Hospital - Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (7)

• 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.

  PMID: 23031764 BACKGROUND

• 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: 27437029 BACKGROUND

• 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.

  PMID: 21262032 BACKGROUND

• 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.

  PMID: 25245730 BACKGROUND

• 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.

  PMID: 12686778 BACKGROUND

• 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.

  PMID: 6835144 BACKGROUND

• 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.

  PMID: 30769215 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Claus A Bertelsen, Ph.D.

  cabertelsen@gmail.com

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: March 17, 2017
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)