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Laparoscopic Antibiotic Lavage to Prevent intra-abdominal Abscess formation in Complicated Appendicitis (ALPACA)
EU CTIS ID: 2024-514850-59-00
What this study is testing
The aim of the study is to evaluate the effect of laparoscopic antibiotic peritoneal lavage with gentamicin and clindamycin for 3 minutes after appendectomy on the incidence of intra-abdominal abscess (IAA) in patients with complicated appendicitis (CA). Our hypothesis is that laparoscopic antibiotic peritoneal lavage will result in a decrease of at least 50% in the incidence of IAA.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All patients ≥ 8 years with a preoperative diagnosis of acute appendicitis either with or without clinical or radiological suspicion of complicated appendicitis undergoing a laparoscopic appendectomy for intra-operative confirmed complicated appendicitis that can provide a signed written consent form.
You likely can't join if
- Age under 8 years
- Immunocompromised patients (i.e. haematological 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
- Not able to give informed consent (language barrier, legally incapable)
See the full eligibility criteria
- All patients ≥ 8 years with a preoperative diagnosis of acute appendicitis either with or without clinical or radiological suspicion of complicated appendicitis undergoing a laparoscopic appendectomy for intra-operative confirmed complicated appendicitis that can provide a signed written consent form.
- Age under 8 years
- Immunocompromised patients (i.e. haematological 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
- Not able to give informed consent (language barrier, legally incapable)
- Appendix not removed
- Uncomplicated appendicitis
- A larger resection (e.g. ileocaecal resection)
- Conversion to open appendectomy
- Any contraindication for the use of the study medication
- 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
- Current malignancy treated with a form of immunomodulation
- Renal insufficiency (i.e., eGFR < 60) in adults (≥18 years of age)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.