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Polymerase Chain Reaction (PCR) and Cultivation of the Peritoneal Fluid at Operation for Appendicitis and Postoperative Enteral Antibiotic Treatment (PACPAT)

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ClinicalTrials.gov Identifier: NCT04713527
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
University of Southern Denmark

Brief Summary:

Patients diagnosed with acute appendicitis receives antibiotics during the operation, and only patients where the surgeon suspects a complicated appendicitis with spread inflammation to the abdominal cavity receive antibiotics for 3 days postoperative.

In a previous study at the surgical department, the investigators were able to show that the surgeon's assessment during the surgery of whether the appendicitis are complicated or not is very uncertain. This means that some patients receive antibiotics after surgery for no reason, and others might have benefited from antibiotics. The aim of this study is to solve this problem.

By extracting some of the peritoneal fluid, it is possible to investigate whether there are bacteria or not in the abdominal cavity. Today when the fluid is cultivated, the answer will appear after 3-4 days. Therefore a new method is needed which confirms the presence of bacteria in the abdominal cavity within 24 hours.

In this study growth of bacteria in cultivation is examined and determined within 24 hours. The study also want to use PCR analysis. It is a special technique, which examines the fluid from the abdominal cavity for bacteria and provide answer within a few hours. It is investigated whether it is possible to perform this method in the daily routine of the department.

New research also shows that if patients needs antibiotics after surgery they can be treated with tablets instead of injection into the blood vessel. Antibiotic treatment with tablets will mean that the patient can be discharged earlier.

The primary purpose of this study is to investigate whether it is possible with the PCR technique or cultivation to determine whether there are bacteria in the abdominal cavity of patients undergoing surgery for acute appendicitis or not, so that any continued antibiotic treatment after surgery can be targeted to the individual patient. The secondary purpose is to investigate whether antibiotic treatment with tablets are as effective as getting antibiotics into the blood vessel.

The patients participating in the project will undergo the usual routine treatment and surgery. The only exception is retrieval of the naturally occurring fluid from the abdominal cavity. This will be done during the operation by special suction equipment that can be fitted to the usual operating equipment. It will not cause any discomfort or inconvenience to the patient. The technique of extracting fluid from the abdominal cavity has been used in previous studies of patients operated on for acute appendicitis.

The benefit for the patient will be a more targeted antibiotic treatment so that both unnecessary treatment is avoided, and patients who previously would not have received treatment can benefit from this. For society a more targeted antibiotic treatment will mean less risk of developing resistance and less hospitalization.


Condition or disease Intervention/treatment
Appendicitis Acute Diagnostic Test: Cultivation and PCR within 24 hours Drug: Enteral antibiotics

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polymerase Chain Reaction and Cultivation of the Peritoneal Fluid at Operation for Appendicitis and Postoperative Enteral Antibiotic Treatment. A Feasibility and Non-inferiority Study
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : January 29, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Cultivation and PCR within 24 hours
    During operation for appendicitis peritoneal fluid will be extracted. This is sent to cultivation and PCR analysis to determine if there is bacteria within the peritoneal cavity.
  • Drug: Enteral antibiotics
    Patients with complicated appendicitis will receive enteral antibiotics instead of intravenous


Primary Outcome Measures :
  1. Cultivation answer within 24 hours [ Time Frame: 24 hours after surgery ]
    A sample of peritoneal fluid is observed for growth of bacteria in Department of Clinical Microbiology within 24 hours after surgery. The answer is either positive (growth of bacteria) or negative (no growth of bacteria).

  2. PCR answer within 24 hours [ Time Frame: 24 hours after surgery ]
    A sample of peritoneal fluid is analysed with the PCR-method. The outcome is either positive (detection of bacterial DNA) or negative (no detection of bacterial DNA)

  3. Complications [ Time Frame: 30 days follow up ]
    Wound infection, intraabdominal abscess and other


Secondary Outcome Measures :
  1. Descriptive data - sex [ Time Frame: 1 day ]
    Female or male is registred. Data is collected from the patients personal journal.

  2. Descriptive data - height [ Time Frame: 1 day ]
    The patients height in centimeters is registred. Data is collected from the patients personal journal.

  3. Descrriptive data - weight [ Time Frame: 1 day ]
    The patients weight in kilograms are registred. Data is collected from the patients personal journal.

  4. Descriptive data - American Society of Anesthesiologists (ASA) score [ Time Frame: 1 day ]
    ASA I: A normal healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life ASA V: Moribund patinet who is not expected to survive without the operation Data is collected from the patients personal journal.

  5. Descriptive data - smoking status [ Time Frame: 1 day ]
    It is registred if the patient is a smoker, former smoker or non-smoker. Also packages years are calculated. Data is collected from the patients personal journal.

  6. Descrptive data - alcohol status [ Time Frame: 1 day ]
    It is registred if the patients drinks more alcohol items a week than 7 items for women and 14 items for men. Data is collected from the patients personal journal.

  7. Descriptive data - Systemic Inflammatoric Response Syndrome (SIRS) criteria [ Time Frame: 1 day ]
    SIRS is defined as fulfilling at least two of the following four criteria: fever >38.0°C or hypothermia <36.0°C, tachycardia >90 beats/minute, tachypnea >20 breaths/minute, leucocytosis >12*109/l or leucopoenia <4*109/l. Data is collected from the patients personal journal.


Biospecimen Retention:   Samples With DNA
Peritoneal Fluid.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Admitted by the Emergency Department (FAM), at OUH or Svendborg
Criteria

Inclusion Criteria:

  • Patients undergoing diagnostic laparoscopy with suspected acute appendicitis
  • Admitted by the Emergency Department (FAM), at Odense University Hospital (OUH) or Svendborg
  • Gets a laparoscopic appendectomy.
  • Speaks and understands Danish

Exclusion Criteria:

  • Age under 18
  • Pregnant or breastfeeding
  • Language difficulties
  • Sepsis preoperatively assessed via the SIRS criteria leading to preoperatively administered antibiotics.
  • Patients with known gastrointestinal disorders as chronic inflammatory bowel disease or previous cancer disease.
  • Open appendectomy
  • Other illness than acute appendicitis

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): NCT04713527


Contacts
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Contact: Regitze DS Sørensen, Stud. med. + 45 26 18 78 95 regitze.ditte.bro.sorensen@rsyd.dk
Contact: Niels Qvist, Professor + 45 29 69 46 25 niels.qvist@rsyd.dk

Locations
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Denmark
Odense University Hospital, OUH Recruiting
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Publications:

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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04713527    
Other Study ID Numbers: 115-2019-NQ
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
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
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents