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Clinical Trials/2024-515834-34-00
2024-515834-34-00
Not yet recruiting
Phase 3

The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis (other than for generalized peritonitis): a prospective, randomized, open-label, non-inferiority Phase III study.

Centre Hospitalier Universitaire Amiens Picardie18 sites in 1 country1,494 target enrollmentStarted: November 20, 2024Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Enrollment
1,494
Locations
18
Primary Endpoint
proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the centre of disease control and prevention (CDC) (29) as infections that occur within 30 days of surgery AND appear to be related to the surgery AND affect the organ or the cavity around the surgical site (i.e. any anatomical structure – other than the incision – that is opened or handled during surgery) AND for which at least one sign defined in the protocol is observed
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

evaluate the impact of the absence of post-operative antibiotic therapy on the organ space surgical site infection (SSI) rate in patients presenting with CAA (other than in cases of generalized peritonitis).

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •CAA confirmed peroperatively by the presence of a perforated appendicitis, extraluminal fecaliths, abscesses and/or localized peritonitis (pus in one or two abdominal quadrants out of four: upper left, upper right, lower left or lower right). Actually, there is no official definition of what a localized CAA is, however Ross (J.Ross. Secondary peritonitis: principles of diagnosis and intervention, BMJ. 2018; 361) define localized peritonitis as infection to one or two quadrants out of four (upper left, upper left, lower left or lower right)
  • •Laparoscopic appendectomy
  • •Aged 18 or over

Exclusion Criteria

  • •Patients with cardiac valvulopathy
  • •d) Contra-indication to the use of ceftriaxone (hypersensibility to the active substance, to another cephalosporin, to the excipient of the used speciality), history of severe hypersesibility (as anaphylactic shock), history of hypersensibility to another antibiotic of the beta-lactamin family (penicillin, monobactam, carbapénèmes)
  • •e) Contra-indication to the use of levofloxacin, hypersensibility to levofloxacin, to another quinolone or to the excipient of one of the use speciality, hypersensibility to levofloxacine ou any other quinolone or to any excipient, epilepsia, history of tendinitis when injection of fluoroquinolones
  • •Living at more than one hour from an hospital
  • •b) Patient who has no relative or other third person who could be present at home and provide assistance in case of any problem for the discharged patient
  • •Non-complicated forms (catarrhal appendicitis or the absence of extraluminal fecaliths, abscess or peritonitis).
  • •Generalized purulent or stercoral peritonitis (the presence of pus or faeces in more than two quadrants of the abdomen out of four).
  • •Pregnancy or breastfeeding.
  • •Patient under guardianship
  • •Immunodepressed patients

Outcomes

Primary Outcomes

proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the centre of disease control and prevention (CDC) (29) as infections that occur within 30 days of surgery AND appear to be related to the surgery AND affect the organ or the cavity around the surgical site (i.e. any anatomical structure – other than the incision – that is opened or handled during surgery) AND for which at least one sign defined in the protocol is observed

proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the centre of disease control and prevention (CDC) (29) as infections that occur within 30 days of surgery AND appear to be related to the surgery AND affect the organ or the cavity around the surgical site (i.e. any anatomical structure – other than the incision – that is opened or handled during surgery) AND for which at least one sign defined in the protocol is observed

Secondary Outcomes

  • Quality of life prior to surgery and on discharge, using the SF36 questionnaires.
  • The proportion of patients with superficial SSIs
  • The post-operative infection rates by POD30, including SSIs and remote infections
  • The number of antibiotic-free days between randomization and POD30.
  • The description of the microbial flora, as found in the antibiogram of the per-operative sample that is collected in all cases
  • The balance between antibiotic therapy and microbial resistance. The antibiotic treatment will be considered to be adequate if no germs are found in the per-operative sample or if all of the detected germs are sensitive to the administered antibiotic therapy. The antibiotic treatment will be considered to be inadequate if the per-operative sample is positive for resistant germs
  • Morbidity and mortality according to the Dindo-Clavien classification (31) and the CCI, Slankamenac, Ann Surg, 2014; 260:757-62) (32)
  • LOS, defined as the number of days of hospitalization between surgery and discharge
  • The rehospitalization rate, defined as rehospitalization during the study period

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Boussault

Scientific

Centre Hospitalier Universitaire Amiens Picardie

Study Sites (18)

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