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Explanations for Negative Laparoscopic Appendectomies and Normal Laparoscopies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03349814
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Siv Fonnes, Herlev Hospital

Brief 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.


Condition or disease Intervention/treatment
Appendicitis Yersinia Enterocolitica Infection Yersinia Pseudotuberculosis Infections Appendectomy Procedure: Diagnostic laparoscopy without appendectomy Procedure: Diagnostic laparoscopy with appendectomy

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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Explanations for Negative Laparoscopic Appendectomies and Normal Laparoscopies. What Does the Patient Suffer From When the Appendix Proves to be Healthy?
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Group/Cohort Intervention/treatment
Appendicitis group

Patients, who undergo a diagnostic laparoscopy, which because of the operative findings leads to an appendectomy, and the appendix is found to be inflamed in the pathology report.

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

Procedure: Diagnostic laparoscopy with appendectomy
A diagnostic laparoscopy where the appendix seems inflamed, and therefore is removed

Normal appendix group

Patients, who undergo a diagnostic laparoscopy, that either because of the operative findings (mesenteric lymphadenitis or normal diagnostic laparoscopy) does not lead to appendectomy, or leads to appendectomy, but the appendix is not found to be inflamed in the pathology report.

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

OR

A diagnostic laparoscopy where the appendix seems inflamed, and therefore is removed, but is not found to be inflamed in the pathology report.

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




Primary Outcome Measures :
  1. Detection of infection with Yersinia spp. (enterocolitica and/or pseudotuberculosis) by microbiological investigation of rectal swab [ Time Frame: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year. ]
    Specimens (rectal swab) collected prior to surgery are immediately frozen at -80°C and stored at Herlev Hospital in a research biobank. When the last patient has concluded the trial, a fraction of the collected specimens from each patient is sent to the Department of Clinical Microbiology, Hvidovre Hospital and thereafter investigated with a real time PCR for Yersinia spp. These results are noted in the patient's eCRF, but not in the patient's medical record. Samples with a positive PCR result will be cultured for Yersinia spp. and in case of positive culture results, susceptibility testing will be performed (secondary outcome). Hereafter, the collected human material and the cultured Yersinia enterocolitica will be frozen at -80°C and stored for ten years at Hvidovre Hospital as a biobank for future research.


Secondary Outcome Measures :
  1. Serology of Yersinia enterocolitica [ Time Frame: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year. ]
    This outcome will be reported on in the planned publication if sufficient funding is achieved, otherwise, it will be presented in a later publication. Six ml of blood collected prior to surgery are immediately frozen at -80°C and stored at Herlev Hospital in a research biobank. When the last patient has concluded the trial, the blood sample for serology from each patient is sent to Statens Serum Institut. Here, the blood samples are investigated a soon as possible after arrival with an in-house ELISA test for Yersinia enterocolitica IgM, IgA, and IgG. After the analysis, the serum samples will be frozen at -80°C and stored for ten years at Statens Serum Institut as a biobank for future research. Thereafter, the samples will be anonymized and transferred to the biobank for future research belonging to Statens Serum Institut.

  2. Detection of infection with Yersinia spp. by either serology or PCR for Yersinia spp. [ Time Frame: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year. ]
    See descriptions for outcome 1 and outcome 2. The overall prevalence of Yersinia spp. detected by either serology or PCR will be reported. This outcome will be based on the cumulative results from both methods. This outcome will only be reported if funding is achieved.

  3. Detection of Campylobacter spp. [ Time Frame: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year. ]

    The specimens (rectal swab) collected prior to surgery are immediately frozen at -80°C and stored at Herlev Hospital in a research biobank. When the last patient has concluded the trial, a fraction of the collected specimens from each patient is sent to the Department of Clinical Microbiology, Hvidovre Hospital and thereafter investigated with a multiplex real time PCR for Campylobacter spp.

    Samples with positive PCR results for bacterial pathogens will be cultured (including Yersinia spp.) and in case of positive culture, susceptibility testing will be performed. Hereafter, the collected human material and the cultured bacteria will be frozen at -80°C and stored for ten years at that site as a research biobank, hereafter samples are anonymized.


  4. Detection of Salmonella spp. [ Time Frame: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year. ]

    The specimens (rectal swab) collected prior to surgery are immediately frozen at -80°C and stored at Herlev Hospital in a research biobank. When the last patient has concluded the trial, a fraction of the collected specimens from each patient is sent to the Department of Clinical Microbiology, Hvidovre Hospital and thereafter investigated with a multiplex real time PCR for Salmonella spp.

    Samples with positive PCR results for bacterial pathogens will be cultured (including Yersinia spp.) and in case of positive culture, susceptibility testing will be performed. Hereafter, the collected human material and the cultured bacteria will be frozen at -80°C and stored for ten years at that site as a research biobank, hereafter samples are anonymized.


  5. Detection of Shigella spp. [ Time Frame: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year. ]

    The specimens (rectal swab) collected prior to surgery are immediately frozen at -80°C and stored at Herlev Hospital in a research biobank. When the last patient has concluded the trial, a fraction of the collected specimens from each patient is sent to the Department of Clinical Microbiology, Hvidovre Hospital and thereafter investigated with a multiplex real time PCR for Shigella spp.

    Samples with positive PCR results for bacterial pathogens will be cultured (including Yersinia spp.) and in case of positive culture, susceptibility testing will be performed. Hereafter, the collected human material and the cultured bacteria will be frozen at -80°C and stored for ten years at that site as a research biobank, hereafter samples are anonymized.


  6. Detection of Aeromonas spp. [ Time Frame: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year. ]

    The specimens (rectal swab) collected prior to surgery are immediately frozen at -80°C and stored at Herlev Hospital in a research biobank. When the last patient has concluded the trial, a fraction of the collected specimens from each patient is sent to the Department of Clinical Microbiology, Hvidovre Hospital and thereafter investigated with a multiplex real time PCR for Aeromonas spp.

    Samples with positive PCR results for bacterial pathogens will be cultured (including Yersinia spp.) and in case of positive culture, susceptibility testing will be performed. Hereafter, the collected human material and the cultured bacteria will be frozen at -80°C and stored for ten years at that site as a research biobank, hereafter samples are anonymized.



Biospecimen Retention:   Samples With DNA

Serology samples: collected for the current research project, analyzed at Statens Serum Institut (SSI), and thereafter anonymized and transferred to the biobank of SSI.

EDTA-blood samples, serum-blood samples and buffycoat: collected only for the biobank for future research. Stored for 10 years at Herlev Hospital, and thereafter destroyed.

Rectal swab: collected for the current research project. Appendix swab: collected only for the biobank for future research. Stored at Herlev Hospital in the biobank for future research for 10 years, thereafter destroyed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any adult with suspection of acute appendicits can be included in the study, unless they have known inflammatory bowel disease or another intra-abdominal pathology that appendicitis.
Criteria

Inclusion Criteria:

  • Suspicion of acute appendicitis and planned for diagnostic laparoscopy
  • Written informed consent after written and verbal information

Exclusion Criteria:

  • Cannot understand, read or speak Danish
  • Known with inflammatory bowel disease
  • Other intra-abdominal pathology than appendicitis requiring other surgical intervention or treatment (diagnosed either perioperatively, at a preoperative CT-scan, or shortly after the surgery in the histopathological examination)
  • Not undergoing diagnostic laparoscopy, laparoscopic appendectomy, or open appendectomy
  • Use of antimicrobial agents within two weeks prior to inclusion until actual admission for acute abdominal pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349814


Locations
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Denmark
Herlev Hospital
Herlev, Capital Region Of Denmark, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Siv Fonnes, MD Centre for Perioperative Optimization, Department of Surgery, Herlev and Gentofte Hospitals, University of Copenhagen
Publications:
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Responsible Party: Siv Fonnes, MD, PhD-student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03349814    
Other Study ID Numbers: HEH-TR-1
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siv Fonnes, Herlev Hospital:
appendicitis
appendectomy
yersinia
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Appendicitis
Yersinia Infections
Yersinia pseudotuberculosis Infections
Intraabdominal Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections