NCT06000020

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,400 (estimated)
• Sponsor: Nordsjaellands Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis Acute

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic appendectomy	Laparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler.

Timeline

• Start date: 2017-03-17
• Primary completion: 2021-04-01
• Completion: 2026-04-01
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

4 sites across 1 country: Denmark