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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis

RecruitingPhase 3Ages 8 Years - anyAllSpaarne Gasthuis
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In plain words

What the trial is, and whether it could suit you

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 institut

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📋 Eligibility rules (as published)
Inclusion Criteria: * All patients ≥ 8 years with a preoperative diagnosis of acute appendicitis either with or without clinical or radiological suspicion of CA undergoing a laparoscopic appendectomy for intra-operative confirmed CA that can provide a signed written consent form. Exclusion Criteria: * Age under 8 years; * Not able to give informed consent (language barrier, legally incapable) * Any contraindication for the use of the study medication: * Hypersensitivity to clindamycin or to any of the excipients benzyl alcohol, sodium edetate, water, or to lincomycin; * Hypersensitivity to gentamicin or to sodium metabisulfite: particularly in asthmatic patients, this may trigger bronchospasms and anaphylactic shock or to any of the excipients: disodium edetate, sodium hydroxide, sodium metabisulfite (E223), water for injections; * Severe sepsis defined as sepsis-induced tissue hypoperfusion or organ dysfunction that includes any of the following thought to be caused by the infection: * Sepsis-induced hypotension * Lactate above upper limits laboratory normal * Urine output \<0.5 mL/kg/h for more than 2h despite adequate fluid resuscitation * Acute lung injury with PaO2/FiO2 \<250 in the absence of pneumonia as infection source * Acute lung injury with PaO2/FiO2 \<200 in the presence of pneumonia as infection source * Creatinine \>2.0 mg/dL (176.8 μmol/L) * Bilirubin \>2mg/dL (34.2 μmol/L) * Platelet count \< 100,000 μL * Coagulopathy (international normalized ratio (INR) \> 1.5); * ASA IV score; * Known malignancy; * Renal dysfunction (i.e. eGFR ≤ 60); * Immunocompromised patients (i.e. hematological malignancies, HIV/AIDS, bone marrow transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, chemotherapy, dialysis, solid organ transplant, and immunosuppressant use (such as corticosteroids in patients with rheumatoid arthritis)); * Pregnancy; * Known allergies to either gentamicin or clindamycin; * Known colonization of bacteria resistant to either gentamicin or clindamycin;
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What it tests

  • Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin
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Where

11 sites
Zuyderland Medisch Centrum
Heerlen, Netherlands
Máxima MC
Veldhoven, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Dijklander Ziekenhuis
Hoorn, Netherlands
Zaans Medisch Centrum
Zaandam, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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