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Explanations for Negative Laparoscopic Appendectomies and Normal Laparoscopies

NCT03349814 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2019-05-29

No results posted yet for this study

Summary

Trial The aim of the study is to investigate which infectious diseases might mimic the symptoms of acute appendicitis to a degree to cause a diagnostic laparoscopy or laparoscopic appendectomy. The primary outcome is to compare the incidence of Yersinia spp. infection in patients, who undergo surgery due to suspected appendicitis, between those with and without appendicitis detected by polymerase chain reaction on rectal swabs. The secondary outcomes are comparison of the incidence of bacterial pathogens (Campylobacter spp., Salmonella spp., Shigella spp., Aeromonas spp.) and Enterobius vermicularis in the two groups. Rectal swabs, appendix swabs, and blood samples are collected prospectively and research biobanks will be established. Initially, the rectal samples and serology samples will be investigated, and possible biomarkers and results of the appendix swabs will be evaluated at a later time point.

Ethics The trial will be conducted according to the Helsinki II Declaration after approval from both the local Health Research Ethics Committee and the Danish Data Protection Agency. An informed written consent will be collected from the participants prior to inclusion in the study. Data will be stored according to the approval from the Danish Data Protection Agency. This study is conducted in patients with suspected appendicitis. These patients are fully awake and conscious at time of inclusion. The patients included in this study will not experience any adverse effects due to their participation.

Conditions

  • Appendicitis
  • Yersinia Enterocolitica Infection
  • Yersinia Pseudotuberculosis Infections
  • Appendectomy

Interventions

PROCEDURE

Diagnostic laparoscopy without appendectomy

A diagnostic laparoscopy where the appendix is not found to be inflamed, and therefore is not removed.

PROCEDURE

Diagnostic laparoscopy with appendectomy

A diagnostic laparoscopy where the appendix seems inflamed, and therefore is removed

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Siv Fonnes, MD · Centre for Perioperative Optimization, Department of Surgery, Herlev and Gentofte Hospitals, University of Copenhagen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2019-05-15
Completion
2019-05-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349814 on ClinicalTrials.gov