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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.
EU CTIS ID: 2024-515834-34-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- signed ICF
You likely can't join if
- 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).
See the full eligibility 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
- signed ICF
- 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
- Diabetic patients
- Patients who have received an antibiotic treatment within 3 months before the surgery (and having a potential impact on the intestinal flora)
- other diseases (Crohn’s disease, ulcerative colitis, treatment with an immunosuppressive therapy)
- Severe sepsis, septic shock or generalized peritonitis.
- a) A decision to perform open appendectomy.
- b) 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.