Importance of Peritoneal Free Fluid Cultures in Acute Appendicitis

Appendicitis Clinical Trial

— IFFSA  

Official title:

Importance of Peritoneal Free Fluid Cultures in Both Perforated and Non-perforated Appendicitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01953289
• Other study ID #: S-54473
• Status: Withdrawn
• Phase: N/A
• First received: February 19, 2013
• Last updated: July 3, 2015
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.

Description:

Prior to surgery, all patients will receive antibioprophylaxis. In case of free peritoneal fluid, a sample is aspirated and sent for microbiology. A lavage with saline is not necessary. The decision to start postoperative antibiotic is left at the discretion of the surgeon. The decision to leave an abdominal drain is left at the discretion of the surgeon.

The use of a preoperative single dose administration of antibiotics has been extensively studied and found beneficial in the prevention of SSI in appendicitis. However, the use of continued postoperative antibiotics has barely been studied. The sparse evidence that exist does not seem to support its systematic use. During appendectomy the surgeon frequently encounters turbid free fluid, even in non-perforated appendicitis. It is common practice in Belgium to continue antibiotic prophylaxis for 5 days after aspiration and lavage. Although the aspect often seems purulent, it is unknown in what percentage this fluid is contaminated. Also, it is unknown whether after aspiration and lavage intra-abdominal drains are necessary.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 90 Years

Eligibility

Inclusion Criteria:

• Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y

Exclusion Criteria:

• Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age < 6 and > 90y

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Appendicitis

Locations

Country	Name	City	State
Belgium	University Clinics Gasthuisberg	Leuven	Flemish Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis	In case of free peritoneal fluid, a sample will be aspirated and sent for microbiology.	24 hours	No