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

Primary Purpose

Complicated Acute Appendicitis

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
No antibiotics
Antibiotics
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Acute Appendicitis focused on measuring complicated acute appendicitis, post-operative antibiotic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amiens North HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

experimental group

control group

Arm Description

no antibiotherapy post surgery for complicated acute appendicitis (CAA)

antibiotherapy post surgery for complicated acute appendicitis (CAA)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life post surgery using the 36-Item Short Form Health Survey
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
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
post-operative infection rates by POD30, including SSIs and remote infections.
number of antibiotic-free days
number of antibiotic-free days between randomization and POD30
Description of the microbial flora
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
balance between antibiotic therapy and microbial resistance
Evaluation of morbidity and mortality
Evaluation of morbidity and mortality (according to the Dindo-Clavien classification and the Comprehensive Complication Index (CCI)).
Length of hospital stay
Length of hospital stay, defined as the number of days of hospitalization between surgery and discharge
rehospitalization rate
rehospitalization rate, defined as the proportion of patients rehospitalized during the study

Full Information

First Posted
June 7, 2018
Last Updated
May 16, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03688295
Brief Title
The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
Acronym
ABAP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Acute Appendicitis
Keywords
complicated acute appendicitis, post-operative antibiotic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Other
Arm Description
no antibiotherapy post surgery for complicated acute appendicitis (CAA)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
antibiotherapy post surgery for complicated acute appendicitis (CAA)
Intervention Type
Other
Intervention Name(s)
No antibiotics
Intervention Description
Patients will not receive antiobitherapy post surgery for CAA
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Description
Patients will receive antiobitherapy post surgery for CAA
Primary Outcome Measure Information:
Title
proportion of patients having developed organ space surgical site infections (SSIs) by postoperative day (POD)30
Description
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.
Time Frame
postoperative day 30
Secondary Outcome Measure Information:
Title
Quality of life post surgery using the 36-Item Short Form Health Survey
Description
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)
Time Frame
day 0 and day 30
Title
proportion of patients with superficial SSIs
Description
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).
Time Frame
postoperative day 30
Title
post-operative infection rates
Description
post-operative infection rates by POD30, including SSIs and remote infections.
Time Frame
postoperative day 30
Title
number of antibiotic-free days
Description
number of antibiotic-free days between randomization and POD30
Time Frame
postoperative day 30
Title
Description of the microbial flora
Description
Description of the microbial flora found in the antibiogram of the per-operative sample collected in all cases
Time Frame
Day 0
Title
balance between antibiotic therapy and microbial resistance
Description
balance between antibiotic therapy and microbial resistance
Time Frame
postoperative day 30
Title
Evaluation of morbidity and mortality
Description
Evaluation of morbidity and mortality (according to the Dindo-Clavien classification and the Comprehensive Complication Index (CCI)).
Time Frame
postoperative day 30
Title
Length of hospital stay
Description
Length of hospital stay, defined as the number of days of hospitalization between surgery and discharge
Time Frame
postoperative day 30
Title
rehospitalization rate
Description
rehospitalization rate, defined as the proportion of patients rehospitalized during the study
Time Frame
postoperative day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc Regimbeau, PD
Phone
33 3.22.08.88.93
Email
Regimbeau.Jean-Marc@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Sabbagh, MD
Email
Sabbagh.Charles@chu-amiens.fr
Facility Information:
Facility Name
Amiens North Hospital
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jean marc regimbeau, MD, PhD
Phone
+33 3 22 66 83 00
Email
regimbeau.jean-marc@chu-amiens.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32487213
Citation
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.
Results Reference
derived

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

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