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
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.
|Condition or disease||Intervention/treatment||Phase|
|Complicated Acute Appendicitis||Other: No antibiotics Drug: Antibiotics||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1476 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
no antibiotherapy post surgery for complicated acute appendicitis (CAA)
Other: No antibiotics
Patients will not receive antiobitherapy post surgery for CAA
Active Comparator: control group
antibiotherapy post surgery for complicated acute appendicitis (CAA)
Patients will receive antiobitherapy post surgery for CAA
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688295
|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|