Leave or Laparoscopic Appendectomy With Normal Findings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-17

Study Completion Date

2026-04-01

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.

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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.

Conditions

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Appendicitis Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Diagnostic laparoscopy

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

No interventions assigned to this group

Laparoscopic appendectomy

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

Laparoscopic appendectomy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic appendectomy

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

Intervention Type PROCEDURE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No