Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03688295

The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2023-05-17

1476

Participants Needed

1

Research Sites

395 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected complicated acute appendicitis with a Saint-Antoine score of 3 or less, confirmed during surgery by perforation, extraluminal fecalith, abscess, or localized peritonitis
  • Underwent laparoscopic appendectomy
  • Age 18 years or older
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Heart valve disease
  • Immunodeficiency
  • Diabetes
  • Antibiotic treatment within 3 months before surgery that could affect intestinal flora
  • Other diseases like Crohn's disease or ulcerative colitis
  • Use of immunosuppressive therapy
  • Saint-Antoine score of 4 or 5 indicating non-complicated appendicitis
  • Severe sepsis, septic shock, or generalized peritonitis
  • Planned open appendectomy
  • Reduced dose of Levofloxacin (250 mg/24h) instead of standard dose
  • Allergy to metronidazole or ceftriaxone or other beta-lactam antibiotics
  • Allergy to levofloxacin or other quinolones, epilepsy, or history of tendinitis linked to fluoroquinolones
  • Living more than one hour from a hospital
  • No available relative or helper at home after discharge
  • Non-complicated appendicitis forms during surgery
  • Generalized purulent or stercoral peritonitis
  • Pregnancy or breastfeeding
  • Under legal guardianship
  • Unable to provide informed consent
  • Lack of social security coverage
  • Allergy to metronidazole

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amiens North Hospital

Amiens, France

Actively Recruiting

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Research Team

J

Jean-Marc Regimbeau, PD

CONTACT

C

Charles Sabbagh, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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