Post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis
The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis): a Prospective, Randomized, Placebo-controlled Phase III Study
This study tests if giving antibiotics after laparoscopic surgery for complicated appendicitis can help prevent infections in patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1476 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT03688295 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of post-operative antibiotic therapy in patients who have undergone laparoscopic appendectomy for complicated acute appendicitis. The study aims to determine whether administering antibiotics after surgery can reduce the rate of post-operative infections in this patient population. Participants will be randomly assigned to receive either antibiotics or no antibiotics following their procedure. The trial focuses on patients with specific complications such as perforated appendicitis or abscesses, and aims to provide updated evidence on post-operative care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over who are undergoing laparoscopic appendectomy for complicated acute appendicitis.
Not a fit: Patients with severe sepsis, septic shock, or generalized peritonitis, as well as those with certain pre-existing conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved post-operative care and reduced infection rates for patients undergoing surgery for complicated acute appendicitis.
How similar studies have performed: Previous studies have suggested potential benefits of post-operative antibiotic therapy, but this trial aims to provide more current evidence specifically for complicated acute appendicitis cases.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens
- Amiens North Hospital — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Jean-Marc Regimbeau, PD
- Email: Regimbeau.Jean-Marc@chu-amiens.fr
- Phone: 33 3.22.08.88.93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.