A Phase 3 interventional study of No antibiotics and Antibiotics in Complicated Acute Appendicitis, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 1,476 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Exclusion Criteria:
Pre-operative exclusion criteria:
Related to the treatment:
Related to the patient
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
no antibiotherapy post surgery for complicated acute appendicitis (CAA)
Other: No antibiotics
antibiotherapy post surgery for complicated acute appendicitis (CAA)
Drug: Antibiotics
Patients will not receive antiobitherapy post surgery for 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
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
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)
Time frame: 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).
Time frame: postoperative day 30
post-operative infection rates
post-operative infection rates by POD30, including SSIs and remote infections.
Time frame: postoperative day 30
number of antibiotic-free days
number of antibiotic-free days between randomization and POD30
Time frame: 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
Time frame: Day 0
balance between antibiotic therapy and microbial resistance
balance between antibiotic therapy and microbial resistance
Time frame: 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)).
Time frame: postoperative day 30
Length of hospital stay
Length of hospital stay, defined as the number of days of hospitalization between surgery and discharge
Time frame: postoperative day 30
rehospitalization rate
rehospitalization rate, defined as the proportion of patients rehospitalized during the study
Time frame: postoperative day 30
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Centre Hospitalier Universitaire, Amiens →