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

NCT03688295 | Recruiting Phase 3 DMC

• 2 other identifiers: PI2017_843_00022017-000334-59
• Study Type: interventional
• Target: 1,476
• Locations: 1 country
• Sites: 1

Brief Summary

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

Complicated Acute Appendicitis

Keywords

complicated acute appendicitis; post-operative antibiotic therapy

Outcome Measures

Primary Outcomes (1)

• proportion of patients having developed organ space surgical site infections (SSIs) by postoperative day (POD)30

  primary outcome is the proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the CDCcentre of disease control and prevention (CDC) 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 of the following signs is observed: pus coming from a drain placed in the organ or cavity; germs isolated from a liquid or tissue sample collected aseptically from the organ or cavity; an abscess or another obvious sign of infection of the organ or cavity found by macroscopic examination during subsequent surgery or in a radiological or histopathological examination.

  postoperative day 30

Secondary Outcomes (9)

• Quality of life post surgery using the 36-Item Short Form Health Survey

  day 0 and day 30

• proportion of patients with superficial SSIs

  postoperative day 30

• post-operative infection rates

  postoperative day 30

• number of antibiotic-free days

  postoperative day 30

• Description of the microbial flora

  Day 0

Study Arms (2)

experimental group

OTHER

no antibiotherapy post surgery for complicated acute appendicitis (CAA)

Other: No antibiotics

control group

ACTIVE COMPARATOR

antibiotherapy post surgery for complicated acute appendicitis (CAA)

Drug: Antibiotics

Interventions

No antibiotics OTHER

Patients will not receive antiobitherapy post surgery for CAA

experimental group

Antibiotics DRUG

Patients will receive antiobitherapy post surgery for CAA

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Laparoscopic appendectomy.
• Aged 18 or over
• Written, informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens North Hospital

Amiens, France

RECRUITING

Related Publications (1)

• Sabbagh C, Siembida N, Dupont H, Diouf M, Schmit JL, Boddaert S, Regimbeau JM. The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study). Trials. 2020 Jun 1;21(1):451. doi: 10.1186/s13063-020-04411-1.

  PMID: 32487213 DERIVED

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Jean-Marc Regimbeau, PD

CONTACT

33 3.22.08.88.93; Regimbeau.Jean-Marc@chu-amiens.fr

Charles Sabbagh, MD

CONTACT

Sabbagh.Charles@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: September 28, 2018
• Study Start: February 1, 2019
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

FR (1)