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

Active, not recruiting

• Conditions: Appendicitis Acute
• Interventions: Procedure: Laparoscopic appendectomy

• Registration Number: NCT06000020
• Lead Sponsor: Nordsjaellands Hospital

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.

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.

Study Timeline

• Study Start: 2017-03-17
• Primary Completion: 2021-04-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Last Update Submitted: 2023-08-14
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Risk of surgery on suspicion of acute appendicitis	5 years	Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis

Secondary Outcome Measures

Name	Time	Method
Length of stay	30 days	Time from index surgery to discharge
Postoperative complications	30 days	Postoperative complications according to the 'Clavien-Dindo classification'
Reintervention	30 days	Laparoscopy or laparotomy due to complications

Trial Locations

Locations (4)

Copenhagen University Hospital - Herlev; 🇩🇰 Herlev, Denmark

Copenhagen University Hospital - Bispebjerg; 🇩🇰 Copenhagen NV, Denmark

Copenhagen University Hospital - Hvidovre; 🇩🇰 Hvidovre, Denmark

Copenhagen University Hospital - North Zealand; 🇩🇰 Hillerød, Denmark