Complex acute appendicitis
Conditions
Interventions
Patients will be randomized to either A) stopping antbiotic treatment after 48
hours of intravenous antibiotics (intervention group), or B) continuing
antibiotic treatment for three more days (contr
Sponsors
Heelkunde
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: - age minimum 8 years old (no upper limit) - patients with suspected acute appendicitis, awaiting appendectomy - written informed consent - intraoperative diagnosis of a complex appendicitis*;*A complex appendicitis includes a gangrenous and/or perforated appendicitis, as well as appendicitis with an abscess. For more information and details regarding severity of appendicitis, see 4.1 Population in the studyprotocol (page 19).
Exclusion criteria
Exclusion criteria: - not able to give informed consent - appendectomy à froid - severe sepsis, defined as sepsis-induced tissue hypoperfusion or organ dysfunction - conservative treatment of acute appendicitis - ASA score IV or not able to undergo surgery - known allergy or any other contraindication for the use of the study medication - immunocompromised patients - pregnancy - use of other antibiotics - intraoperative diagnosis of a simple appendicitis - intraoperative appendicular infiltration not amendable for appendectomy - inadequate source control after appendectomy*;*the definition of adequate source control is given in the studyprotocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is a composite endpoint of mortality and infectious complications related to appendectomy including intra-abdominal abscess and surigical site infection. You will find a more detailed definition of the primary endpoint in Chapter 8 (Methods) of the studyprotocol, on page 29. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcomes are amongst others: intra-abdominal abscess, superficial and/or deep surgical site infections, restart of antibiotics, hospital stay in hours, readmission rate and cost-effectiveness. Study variables are: age at time of diagnosis, location of operation, medical history (including diabetes mellitus, corticosteroid use), ASA score, gender, BMI, body temperature and laboratory results at time of presentation (CRP, WBC, eGFR), diagnostic radiological imaging, duration and severity of abdominal pain (VAS scale), antibiotic use prior to clinical diagnosis of acute appendicitis (type and dosage), prophylactic antibiotic use (type and dosage), laparoscopic or open appendectomy, duration of operation (skin-to-skin time), type of appendicitis (phlegmonous, gangrenous or perforated, with or without abscess), degree of peritonitis, level of expertise of surgeon, peritoneal irrigation and/or suction, wound management, use of (endo)loops or (endo)stapler, intraperitoneal drain placement, cultures of intra-abdominal fluid collections, histological type of appendicitis, (time to reach) discharge criteria, postoperative imaging for suspected complications, intra-abdominal abscess (IAA), deep and/or superficial surgical site infection (SSI), treatment of IAAs and SSIs, any other postoperative complication including severity, duration and doses of antibiotics received, restart of antibiotics and type, adverse events on antibiotics, type and resistance profile of cultured micro-organisms postoperatively, length of hospital stay, post-operative outpatient visit, readmission, re-interventions for complications (all within 90 days after appendectomy). | — |
Countries
Netherlands
Outcome results
None listed