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

NCT04713527 | Unknown DMC

• 1 other identifier: 115-2019-NQ
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute

Outcome Measures

Primary Outcomes (3)

• Cultivation answer within 24 hours

  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).

  24 hours after surgery

• PCR answer within 24 hours

  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)

  24 hours after surgery

• Complications

  Wound infection, intraabdominal abscess and other

  30 days follow up

Secondary Outcomes (7)

• Descriptive data - sex

  1 day

• Descriptive data - height

  1 day

• Descrriptive data - weight

  1 day

• Descriptive data - American Society of Anesthesiologists (ASA) score

  1 day

• Descriptive data - smoking status

  1 day

Interventions

Cultivation and PCR within 24 hours DIAGNOSTIC_TEST

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.

Enteral antibiotics DRUG

Patients with complicated appendicitis will receive enteral antibiotics instead of intravenous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Admitted by the Emergency Department (FAM), at OUH or Svendborg

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital, OUH

Odense, 5000, Denmark

RECRUITING

Related Publications (7)

• Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.

  PMID: 26460662 BACKGROUND

• Daskalakis K, Juhlin C, Pahlman L. The use of pre- or postoperative antibiotics in surgery for appendicitis: a systematic review. Scand J Surg. 2014 Mar;103(1):14-20. doi: 10.1177/1457496913497433. Epub 2013 Sep 20.

  PMID: 24056131 BACKGROUND

• van Rossem CC, Schreinemacher MH, Treskes K, van Hogezand RM, van Geloven AA. Duration of antibiotic treatment after appendicectomy for acute complicated appendicitis. Br J Surg. 2014 May;101(6):715-9. doi: 10.1002/bjs.9481. Epub 2014 Mar 26.

  PMID: 24668341 BACKGROUND

• Tind S, Qvist N. Acute Appendicitis: A Weak Concordance Between Perioperative Diagnosis, Pathology and Peritoneal Fluid Cultivation. World J Surg. 2017 Jan;41(1):70-74. doi: 10.1007/s00268-016-3686-8.

  PMID: 27541029 BACKGROUND

• Kleif J, Rasmussen L, Fonnes S, Tibaek P, Daoud A, Lund H, Gogenur I. Enteral Antibiotics are Non-inferior to Intravenous Antibiotics After Complicated Appendicitis in Adults: A Retrospective Multicentre Non-inferiority Study. World J Surg. 2017 Nov;41(11):2706-2714. doi: 10.1007/s00268-017-4076-6.

  PMID: 28600695 BACKGROUND

• National Collaborating Centre for Women's and Children's Health (UK). Surgical Site Infection: Prevention and Treatment of Surgical Site Infection. London: RCOG Press; 2008 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK53731/

  PMID: 21698848 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peritoneal Fluid.

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Central Study Contacts

Regitze DS Sørensen, Stud. med.

CONTACT

+ 45 26 18 78 95; regitze.ditte.bro.sorensen@rsyd.dk

Niels Qvist, Professor

CONTACT

+ 45 29 69 46 25; niels.qvist@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: January 19, 2021
• Study Start: June 22, 2020
• Primary Completion: May 29, 2021
• Study Completion: June 28, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)