Laparoscopic Antibiotic Lavage to Help Prevent Abscess After Complicated Appendicitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this interventional phase 3 study, patients with complicated appendicitis undergoing laparoscopic appendectomy receive laparoscopic antibiotic lavage with gentamicin and clindamycin. The aim is to see if this approach lowers the rate of postoperative intra-abdominal abscesses compared with standard care. Eligible participants are adults and children aged 8 and older with intra-operatively confirmed complicated appendicitis who can consent. Exclusion criteria include age under 8, language or consent barriers, and allergies to the study medications or excipients. The study is sponsored by Spaarne Gasthuis with collaboration from ZonMw and involves multiple Dutch centers.

Why it matters

Who can join: the full rules

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;

Where it's running

• Máxima MC
  Veldhoven, North Brabant, Netherlands Recruiting
• Noordwest Ziekenhuisgroep
  Alkmaar, North Holland, Netherlands Recruiting
• Rode Kruis Ziekenhuis
  Beverwijk, North Holland, Netherlands Recruiting
• Spaarne Gasthuis
  Hoofddorp, North Holland, Netherlands Recruiting
• Dijklander Ziekenhuis
  Hoorn, North Holland, Netherlands Recruiting
• Zaans Medisch Centrum
  Zaandam, North Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Emeline Gebro, Master of science degree
• Email: alpaca@spaarnegasthuis.nl
• Phone: +31(0)23 2241685

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.