Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT03688295
Eligibility Criteria:
Inclusion Criteria:
1. CAA suspected pre-operatively through a Saint-Antoine score ≤3 and confirmed peroperatively by the presence of a perforated appendicitis, extraluminal fecaliths, abscesses and/or localized peritonitis (pus in one or two abdominal quadrants).
2. Laparoscopic appendectomy.
3. Aged 18 or over
4. Written, informed consent
Exclusion Criteria:
1. Pre-operative exclusion criteria:
* Patients with cardiac valvulopathy
* Immunodepressed patients
* Diabetic patients
* Patients who have received an antibiotic treatment within 3 months before the surgery (and having a potential impact on the intestinal flora)
* Related to the diagnosis: other diseases (Crohn's disease, ulcerative colitis, treatment with an immunosuppressive therapy).
* Related to the severity of the appendicitis:
* A Saint-Antoine score of 4 or 5 (non-complicated acute appendicitis)
* Severe sepsis, septic shock, generalized peritonitis
* Related to the treatment:
* A decision to perform open appendectomy.
* Patients who received an adaptive dose of Levofloxacine 250 mg/24H instead of 500 mg/24H in pre-operative or in per-operative (notably for patients with creatinine clearance ≤ 50 ml/min)
* allergy to metronidazole or to one of the excipient
* 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)
* 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.
* Related to the patient
* Living at more than one hour from an hospital
* 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
2. Per-operative exclusion criteria (related to the severity of appendicitis):
* 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).
In order to assess the reproducibility of the inclusion criteria in the various centres and to avoid variations due to the lack of an official definition for localized peritonitis, all centres will receive a video tutorial on localized peritonitis before the start of the study.
* Pregnancy or breastfeeding.
* Patients under guardianship.
* Patients unable to provide informed consent.
* Patient lacking social security coverage
* Allergy to metronidazole
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03688295
Study Brief:
Protocol Section:
NCT03688295