METRONIDAZOLE, GLUCOSE for Complicated acute appendicitis

Inclusion criteria

• {"criterion_text":"- 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)\n- Laparoscopic appendectomy\n- Aged 18 or over\n- signed ICF"}

Exclusion criteria

• {"criterion_text":"- Patients with cardiac valvulopathy\n- d)\tContra-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)\n- e)\tContra-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\n- Living at more than one hour from an hospital\n- b)\tPatient 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\n- Non-complicated forms (catarrhal appendicitis or the absence of extraluminal fecaliths, abscess or peritonitis).\n- Generalized purulent or stercoral peritonitis (the presence of pus or faeces in more than two quadrants of the abdomen out of four).\n- Pregnancy or breastfeeding.\n- Patient under guardianship\n- Immunodepressed patients\n- Diabetic patients\n- Patients who have received an antibiotic treatment within 3 months before the surgery (and having a potential impact on the intestinal flora)\n- other diseases (Crohn’s disease, ulcerative colitis, treatment with an immunosuppressive therapy)\n- Severe sepsis, septic shock or generalized peritonitis.\n- a)\tA decision to perform open appendectomy.\n- b)\tPatients 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)\n- allergy to metronidazole or to one of the excipient"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Deep SSIs defined per CDC: infections occurring within 30 days of surgery related to the surgery affecting organ/cavity around the surgical site; at least one sign defined in the protocol must be observed. Measured as proportion of patients with deep SSIs by postoperative day 30 (POD30)."}

Secondary endpoints

• {"endpoint_text":"- Quality of life prior to surgery and on discharge, using the SF36 questionnaires.","definition_or_measurement_approach":"Measured using SF-36 questionnaires prior to surgery and at discharge."}
• {"endpoint_text":"- The proportion of patients with superficial SSIs","definition_or_measurement_approach":"Measured as proportion of patients with superficial surgical site infections (timing not further specified; part of POD30 outcomes)."}
• {"endpoint_text":"- The post-operative infection rates by POD30, including SSIs and remote infections","definition_or_measurement_approach":"Measured as post-operative infection rates up to postoperative day 30, including surgical site infections and remote infections."}
• {"endpoint_text":"- The number of antibiotic-free days between randomization and POD30.","definition_or_measurement_approach":"Count of days without antibiotics between randomization and postoperative day 30."}
• {"endpoint_text":"- The description of the microbial flora, as found in the antibiogram of the per-operative sample that is collected in all cases","definition_or_measurement_approach":"Descriptive analysis of microbial flora from per-operative samples using antibiogram results."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Categorical assessment of adequacy of antibiotic therapy based on per-operative sample: adequate if no pathogens or all detected pathogens are sensitive to administered antibiotics; inadequate if resistant pathogens are present."}
• {"endpoint_text":"- Morbidity and mortality according to the Dindo-Clavien classification (31) and the CCI, Slankamenac, Ann Surg, 2014; 260:757-62) (32)","definition_or_measurement_approach":"Morbidity and mortality graded by Dindo-Clavien classification and Comprehensive Complication Index (CCI) per referenced publications."}
• {"endpoint_text":"- LOS, defined as the number of days of hospitalization between surgery and discharge","definition_or_measurement_approach":"Length of stay measured as days hospitalized from surgery to discharge."}
• {"endpoint_text":"- The rehospitalization rate, defined as rehospitalization during the study period","definition_or_measurement_approach":"Measured as the proportion of patients rehospitalized during the study period."}

France

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

20-11-2024

Processing Time Days

51

Number Of Sites

19

Number Of Participants

1494

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France