Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin
DrugPeritoneal antibiotic lavage using a solution of gentamicin/clindamycin in NaCl 0.9%.
NCT Number: NCT06841003
Appendicitis is one of the most common causes of acute surgical admission. Presently, two types of appendicitis are distinguished: complicated and uncomplicated (phlegmonous). Complicated appendicitis (CA) is defined as gangrenous and/or perforated appendicitis and/or appendicitis with an intra-abdominal or pelvic abscess. Laparoscopic appendectomy has become the preferential mode of surgical treatment. However, development of an intra-abdominal abscess (IAA) remains an important and clinically relevant complication following appendectomy, especially in complicated appendicitis. Although patients with complicated appendicitis receive postoperative intravenous antibiotics, the incidence of IAA remains considerable. The reported incidence of IAA in children and adults with CA is 7.9% - 24%. We recently reported an IAA rate of 12.3% after laparoscopic appendectomy for CA in our own institution. Patients with IAA are readmitted and treated with either antibiotics, image-guided percutaneous drainage, surgical reintervention, or a combination of these treatments. Furthermore, IAA represents a considerable burden for the healthcare system with high readmission rates and reinterventions, prolonged hospital stay, and therefore increased medical costs. Intra operative techniques aiming at more effective infection source control represent a clinically relevant area of investigation. Laparoscopic antibiotic lavage represents a promising concept in order to reduce intra-abdominal abscess formation. Antibiotic lavage is mainly known for the treatment of peritoneal dialysis associated peritonitis. Several studies show promising results of antibiotic peritoneal lavage on the incidence of surgical site infections (SSIs) including IAA in patients with CA. However, these studies were retrospective or conducted in a small number of patients who underwent an open appendectomy while high quality randomized controlled trials have not been performed yet.
The aim of the ALPACA study is to evaluate the effect of laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin for 3 minutes after appendectomy on the incidence of IAA in patients with CA.
Trial opening soon.
Get Notified8 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Peritoneal antibiotic lavage using a solution of gentamicin/clindamycin in NaCl 0.9%.
Time frame: Within 30 days follow-up
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Time frame: From the moment of start surgery (the incision) to wound closure.
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
Measured by digital questionnaire of EuroQol-5 Dimension (EQ-5D)
Time frame: Within 90-days follow-up
Including emergency department visits, telephone consultations and outpatient consultations
Time frame: Within 90-days follow-up
Cost-effectivity will be determined by IMTA Productivity Cost Questionnaire (iPCQ)
Time frame: Within 90-days follow-up
Time frame: Within 90-days follow-up
The cost-effectivity will be determined by iMTA Medical Consumption Questionnaire
Contact information is provided by the study sponsor or research team.
Spaarne Gasthuis
Other
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis (ALPACA), a Multicenter Single-blinded RCT.
Acronym: ALPACA
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