The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
Around 30% of appendectomies are performed for complicated acute appendicitis (CAA, i.e.
 cases with perforated appendicitis, extraluminal fecaliths, abscesses, or local or
 generalized peritonitis). The treatment of these complicated forms involves the following
 steps: initiation of antibiotic treatment at the time of the diagnosis, appendectomy and
 post-operative antibiotic therapy that continues for 3 days for localized forms of CAA and
 for 5 days for generalized peritonitis (according to the guidelines issued by the French
 Society for Anaesthesia and Critical Care Medicine (SFAR)). The results of a Cochrane
 meta-analysis published in 2005 suggested that the post-operative infection rate was lower in
 patients having receiving antibiotic therapy after surgery for AA. When only cases of CAA
 were considered, the difference was no longer significant. However, it should be noted that
 the studies included in the meta-analysis are now rather old (published before 1995, with
 open procedures) and no longer provide valid data for answering this question because most
 appendectomies (80%) are now performed using laparoscopy. Furthermore, a recent cohort study
 compared a short (3-day) course of antibiotics with a long course (at least 5 days) in
 patients with CAA having undergone laparoscopic or open appendectomy. There was no
 significant intergroup difference in the post-operative complication rate. One can thus
 legitimately question whether post-operative antibiotic therapy is required after
 laparoscopic appendectomy for CAA.

 The purpose of the present study is to 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 cases of generalized peritonitis) by comparing a group of
 patients having undergone a conventional strategy of post-operative antibiotic therapy for
 three days after appendectomy for CAA (the control group) with a group of patients having
 received a post-operative placebo for three days after appendectomy for CAA (the experimental
 group). The primary endpoint will be evaluated at one month after randomization.
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