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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06000020
Enrollment
1435
Registered
2023-08-21
Start date
2017-03-17
Completion date
2025-04-01
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis Acute

Keywords

Laparoscopic appendectomy, Normal findings

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.

Interventions

PROCEDURELaparoscopic appendectomy

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

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Risk of surgery on suspicion of acute appendicitis3 yearsLaparoscopy or laparotomy after surgery on suspicion of acute appendicitis

Secondary

MeasureTime frameDescription
Reintervention30 daysLaparoscopy or laparotomy due to complications
Postoperative complications30 daysPostoperative complications according to the 'Clavien-Dindo classification'
Length of stay30 daysTime from index surgery to discharge

Countries

Denmark

Contacts

STUDY_CHAIRClaus A Bertelsen, Ph.D.

cabertelsen@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026