Gentamicin for Complicated appendicitis | Acute appendicitis

Inclusion criteria

• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Age under 8 years"}
• {"criterion_text":"- 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))"}
• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Known allergies to either gentamicin or clindamycin"}
• {"criterion_text":"- Known colonization of bacteria resistant to either gentamicin or clindamycin"}
• {"criterion_text":"- Not able to give informed consent (language barrier, legally incapable)"}
• {"criterion_text":"- Appendix not removed"}
• {"criterion_text":"- Uncomplicated appendicitis"}
• {"criterion_text":"- A larger resection (e.g. ileocaecal resection)"}
• {"criterion_text":"- Conversion to open appendectomy"}
• {"criterion_text":"- Any contraindication for the use of the study medication"}
• {"criterion_text":"- Severe sepsis defined as sepsis-induced tissue hypoperfusion or organ dysfunction that includes any of the following thought to be caused by the infection: •\tSepsis-induced hypotension •\tLactate above upper limits laboratory normal •\tUrine output <0.5 mL/kg/h for more than 2h despite adequate fluid resuscitation •\tAcute lung injury with PaO2/FiO2 <250 in the absence of pneumonia as infection source •\tAcute lung injury with PaO2/FiO2 <200 in the presence of pneumonia as infection source •\tCreatinine >2.0 mg/dL (176.8 μmol/L) •\tBilirubin >2mg/dL (34.2 μmol/L) •\tPlatelet count < 100,000 μL •\tCoagulopathy (international normalized ratio (INR) > 1.5);"}
• {"criterion_text":"- ASA IV score"}
• {"criterion_text":"- Current malignancy treated with a form of immunomodulation"}
• {"criterion_text":"- Renal insufficiency (i.e., eGFR < 60) in adults (≥18 years of age)"}

Primary endpoints

• {"endpoint_text":"- Incidence of postoperative intra-abdominal abscess within 30 days follow-up","definition_or_measurement_approach":"Incidence of postoperative intra-abdominal abscess measured within a 30-day follow-up period."}

Secondary endpoints

• {"endpoint_text":"- Wound infections (90 days)","definition_or_measurement_approach":"Wound infections assessed within 90 days."}
• {"endpoint_text":"- Treatment of IAA (90 days)","definition_or_measurement_approach":"Treatment of intra-abdominal abscess assessed within 90 days."}
• {"endpoint_text":"- Microbial cultures of intra-operative aspirate and of postoperative IAA (90 days)","definition_or_measurement_approach":"Microbial cultures of intra-operative aspirate and postoperative IAA collected/assessed within 90 days."}
• {"endpoint_text":"- Operating time (time from incision to wound closure - 90 days)","definition_or_measurement_approach":"Operating time measured as time from incision to wound closure; related outcomes considered within 90 days."}
• {"endpoint_text":"- Readmission rate (90 days)","definition_or_measurement_approach":"Readmission rate within 90 days post-procedure."}
• {"endpoint_text":"- Reoperation rate (90 days)","definition_or_measurement_approach":"Reoperation rate within 90 days post-procedure."}
• {"endpoint_text":"- Hospital length-of-stay (including readmission - 90 days)","definition_or_measurement_approach":"Hospital length-of-stay including readmissions, evaluated over 90 days."}
• {"endpoint_text":"- Surgical complications according to the Clavien-Dindo classification (90 days)","definition_or_measurement_approach":"Surgical complications classified by Clavien-Dindo within 90 days."}
• {"endpoint_text":"- Mortality (90 days)","definition_or_measurement_approach":"All-cause mortality within 90 days."}
• {"endpoint_text":"- Adverse events of antibiotic peritoneal lavage (90 days)","definition_or_measurement_approach":"Adverse events related to the antibiotic peritoneal lavage recorded within 90 days."}
• {"endpoint_text":"- Quality of life (90 days)","definition_or_measurement_approach":"Quality of life measurements collected within 90 days (patient-facing questionnaires included in documents)."}
• {"endpoint_text":"- Postoperative consultations (90 days)","definition_or_measurement_approach":"Postoperative consultations tracked within 90 days."}
• {"endpoint_text":"- Cost-effectivity (90 days)","definition_or_measurement_approach":"Cost-effectiveness analysis over a 90-day time horizon."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-12-2024

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

449

Number Of Sites

12

Number Of Participants

752

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"ZonMw - Goed Gebruik Geneesmiddelen - Grote Trials Ronde 6","duties_or_roles":"Funding","organisation_type":""}
• {"country":"","full_name":"Spaarne Gasthuis Science Fund","duties_or_roles":"Funding","organisation_type":""}

Co-sponsors

• Spaarne Gasthuis Stichting