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Completed

NCT Number: NCT06000020

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital - Bispebjerg, Copenhagen NV, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic appendectomy

Procedure

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

Primary outcomes

  1. Risk of surgery on suspicion of acute appendicitis

    Time frame: 3 years

    Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis

  2. Risk of surgery on suspicion of acute appendicitis

    Time frame: 5 years

    Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis

Secondary outcomes

  1. Reintervention

    Time frame: 30 days

    Laparoscopy or laparotomy due to complications

  2. Postoperative complications

    Time frame: 30 days

    Postoperative complications according to the 'Clavien-Dindo classification'

  3. Length of stay

    Time frame: 30 days

    Time from index surgery to discharge

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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