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
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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