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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Appendicitis Acute

Intervention / Treatment
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* Procedure: Laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic laparoscopy<br>Diagnostic laparoscopy on suspicion of acute appendicitis with normal intraoperative findings (including mesenteric adenitis). | |
| Laparoscopic appendectomy<br>Laparoscopic appendectomy despite normal intraoperative findings (including mesenteric adenitis) and histopathology showing a normal appendix. | Procedure: Laparoscopic appendectomy<br>* Laparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintervention | Laparoscopy or laparotomy due to complications | 30 days | 
| Postoperative complications | Postoperative complications according to the 'Clavien-Dindo classification' | 30 days | 
| Length of stay | Time from index surgery to discharge | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic appendectomy, Normal findings