Complicated Acute AppendicitisPhase 3ABAPNCT03688295
The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
A Phase 3 study testing No antibiotics and Antibiotics in people with Complicated Acute Appendicitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Acute Appendicitis
- What is being tested?
- No antibiotics and Antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,476 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 1 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Charles Sabbagh, MD contact
France1 site, 1 recruiting
- Recruiting
Amiens North Hospital
Amiens
jean marc regimbeau, MD, PhD, +33 3 22 66 83 00, regimbeau.jean-marc@chu-amiens.fr
About this study
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
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
- Being tested
- No antibiotics, Antibiotics
- Keywords
- complicated acute appendicitis, post-operative antibiotic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No antibioticsOther
Patients will not receive antiobitherapy post surgery for CAA
AntibioticsDrug
Patients will receive antiobitherapy post surgery for CAA
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Other | no antibiotherapy post surgery for complicated acute appendicitis (CAA) Receives: Other: No antibiotics |
| control group | Active comparator | antibiotherapy post surgery for complicated acute appendicitis (CAA) Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 30
Secondary outcomes (9)
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)
Measured: day 0 and day 30
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).
Measured: postoperative day 30
post-operative infection rates
post-operative infection rates by POD30, including SSIs and remote infections.
Measured: postoperative day 30
number of antibiotic-free days
number of antibiotic-free days between randomization and POD30
Measured: postoperative day 30
Description of the microbial flora
Description of the microbial flora found in the antibiogram of the per-operative sample collected in all cases
Measured: Day 0
balance between antibiotic therapy and microbial resistance
balance between antibiotic therapy and microbial resistance
Measured: postoperative day 30
Evaluation of morbidity and mortality
Evaluation of morbidity and mortality (according to the Dindo-Clavien classification and the Comprehensive Complication Index (CCI)).
Measured: postoperative day 30
Length of hospital stay
Length of hospital stay, defined as the number of days of hospitalization between surgery and discharge
Measured: postoperative day 30
rehospitalization rate
rehospitalization rate, defined as the proportion of patients rehospitalized during the study
Measured: postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Feb 2019
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688295
- Sponsor's protocol ID
- PI2017_843_0002
- Other IDs
- 2017-000334-59, 2017
- Acronym
- ABAP
- Status last verified
- May 2023
- First submitted
- 7 Jun 2018
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32487213
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03688295
- Acronym / sponsor ID
- ABAP / PI2017_843_0002
- Conditions
- Complicated Acute Appendicitis
- Keywords
- complicated acute appendicitis, post-operative antibiotic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,476 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Other | Other: No antibioticsno antibiotherapy post surgery for complicated acute appendicitis (CAA) |
| control group | Active comparator | Drug: Antibioticsantibiotherapy post surgery for complicated acute appendicitis (CAA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (27 listed)
- Pre-operative exclusion criteria:
- Per-operative exclusion criteria (related to the severity of appendicitis):
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No antibioticsPatients will not receive antiobitherapy post surgery for CAA | Other | experimental group |
| AntibioticsPatients will receive antiobitherapy post surgery for CAA | Drug | control group |
Primary outcome
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.
9 secondary outcomes
Quality of life post surgery using the 36-Item Short Form Health Survey
Time frame: day 0 and day 30
proportion of patients with superficial SSIs
Time frame: postoperative day 30
post-operative infection rates
Time frame: postoperative day 30
number of antibiotic-free days
Time frame: postoperative day 30
Description of the microbial flora
Time frame: Day 0
balance between antibiotic therapy and microbial resistance
Time frame: postoperative day 30
Evaluation of morbidity and mortality
Time frame: postoperative day 30
Length of hospital stay
Time frame: postoperative day 30
rehospitalization rate
Time frame: postoperative day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 32487213Sabbagh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Sabbagh, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing No antibiotics and Antibiotics in people with Complicated Acute Appendicitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Regimbeau, PD (33 3.22.08.88.93, Regimbeau.Jean-Marc@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients having developed organ space surgical site infections (SSIs) by postoperative day (POD)30 (time frame: postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.