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

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ClinicalTrials.gov Identifier: NCT03688295
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Tracking Information
First Submitted Date  ICMJE June 7, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date September 28, 2018
Estimated Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
proportion of patients having developed organ space surgical site infections (SSIs) by postoperative day (POD)30 [ Time Frame: postoperative day 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Quality of life post surgery using the 36-Item Short Form Health Survey [ Time Frame: day 0 and day 30 ]
    Quality of life on day 0 and day 30 post surgery, with the 36-Item Short Form Health Survey questionnaires (0 = very bad, 100 = very good)
  • proportion of patients with superficial SSIs [ Time Frame: postoperative day 30 ]
    The proportion of patients with superficial SSIs, defined as infections that occur within 30 days of the intervention AND affect the skin and subcutaneous tissue AND or which at least one of the following signs is observed: pus coming from the superficial part of the incision, germs isolated from a liquid or tissue sample collected aseptically from the superficial part of the incision, a sign of infection (pain, tenderness, redness, burning, etc.) associated with deliberate opening of the superficial part of the incision by the surgeon (except if the culture is negative). Infection of the superficial part of the incision is diagnosed by the surgeon (or the physician attending to the patient).
  • post-operative infection rates [ Time Frame: postoperative day 30 ]
    post-operative infection rates by POD30, including SSIs and remote infections.
  • number of antibiotic-free days [ Time Frame: postoperative day 30 ]
    number of antibiotic-free days between randomization and POD30
  • Description of the microbial flora [ Time Frame: Day 0 ]
    Description of the microbial flora found in the antibiogram of the per-operative sample collected in all cases
  • balance between antibiotic therapy and microbial resistance [ Time Frame: postoperative day 30 ]
    balance between antibiotic therapy and microbial resistance
  • Evaluation of morbidity and mortality [ Time Frame: postoperative day 30 ]
    Evaluation of morbidity and mortality (according to the Dindo-Clavien classification and the Comprehensive Complication Index (CCI)).
  • Length of hospital stay [ Time Frame: postoperative day 30 ]
    Length of hospital stay, defined as the number of days of hospitalization between surgery and discharge
  • rehospitalization rate [ Time Frame: postoperative day 30 ]
    rehospitalization rate, defined as the proportion of patients rehospitalized during the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Complicated Acute Appendicitis
Intervention  ICMJE
  • Other: No antibiotics
    Patients will not receive antiobitherapy post surgery for CAA
  • Drug: Antibiotics
    Patients will receive antiobitherapy post surgery for CAA
Study Arms  ICMJE
  • experimental group
    no antibiotherapy post surgery for complicated acute appendicitis (CAA)
    Intervention: Other: No antibiotics
  • Active Comparator: control group
    antibiotherapy post surgery for complicated acute appendicitis (CAA)
    Intervention: Drug: Antibiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
1476
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Marc Regimbeau, PD 33 3.22.08.88.93 Regimbeau.Jean-Marc@chu-amiens.fr
Contact: Charles Sabbagh, MD Sabbagh.Charles@chu-amiens.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688295
Other Study ID Numbers  ICMJE PI2017_843_0002
2017-000334-59 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP