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

NCT04713527 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-05-05

No results posted yet for this study

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.

Conditions

  • Appendicitis Acute

Interventions

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

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER
  • University of Southern Denmark

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2021-05-29
Completion
2021-06-28

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 NCT04713527 on ClinicalTrials.gov