Evaluation of Laparoscopic Peritoneal Lavage with Gentamicin and Clindamycin for Reducing Intra-Abdominal Abscess in Complicated Appendicitis

The primary objective of this study is to evaluate the effect of **laparoscopic antibiotic peritoneal lavage** using gentamicin and clindamycin for 3 minutes post-appendectomy on the incidence of intra-abdominal abscess (IAA) in patients with complicated appendicitis. This is clinically relevant as reducing the incidence of IAA can significantly improve patient outcomes and reduce postoperative complications associated with appendicitis.

Secondary objectives include assessing various clinical and surgical outcomes such as:

• Wound infections
• Treatment of IAA
• Microbial cultures of intra-operative aspirate and postoperative IAA
• Operating time (from incision to wound closure)
• Readmission rate
• Reoperation rate
• Hospital length-of-stay (including readmission)
• Surgical complications according to the Clavien-Dindo classification
• Mortality
• Adverse events of antibiotic peritoneal lavage
• Quality of life
• Postoperative consultations
• Cost-effectivity

The clinical trial focuses on patients diagnosed with **appendicitis**, specifically targeting those with complicated appendicitis undergoing laparoscopic appendectomy. The study population includes both male and female participants aged 8 years and older. The trial does not specify the total number of participants, as the sponsor has not provided this information. Participants were selected based on their preoperative diagnosis of acute appendicitis, with or without clinical or radiological suspicion of complication, and must be able to provide signed written consent. The trial includes a vulnerable population, indicating that special considerations are in place to ensure their protection. The study does not specify any particular lifestyle considerations such as diet or physical activity. The inclusion criteria emphasize the need for intra-operative confirmation of complicated appendicitis. The trial aims to assess the impact of laparoscopic antibiotic peritoneal lavage on the incidence of intra-abdominal abscess post-appendectomy.

The clinical trial is designed to evaluate the effect of **laparoscopic antibiotic peritoneal lavage** using **gentamicin** and **clindamycin** on the incidence of intra-abdominal abscess in patients with complicated appendicitis. This study is a multicenter, single-blinded, randomized controlled trial. The trial is expected to commence on January 1, 2025, and conclude by April 1, 2027. Participants will be involved in the study for a maximum of 90 days, with the primary endpoint being the incidence of postoperative intra-abdominal abscess within a 30-day follow-up period. Secondary endpoints include wound infections, treatment of intra-abdominal abscess, microbial cultures, operating time, readmission rate, reoperation rate, hospital length-of-stay, surgical complications, mortality, adverse events, quality of life, postoperative consultations, and cost-effectivity, all assessed over a 90-day period.

The trial will begin with a screening visit to confirm eligibility, which includes patients aged 8 years and older with a preoperative diagnosis of acute appendicitis undergoing laparoscopic appendectomy for intra-operatively confirmed complicated appendicitis. Participants must provide signed written consent. Following the screening, eligible participants will be randomized to receive the antibiotic lavage. Study visits will include follow-up assessments at 30 and 90 days post-procedure to monitor for the primary and secondary endpoints. The end-of-study visit will occur at the 90-day mark, concluding the participant's involvement in the trial. Conditions that may lead to early termination from the study include withdrawal of consent, occurrence of adverse events necessitating discontinuation, or any protocol violations that compromise the integrity of the study data.

The clinical trial involves the use of two **experimental medications**: **Clindamycin** and **Gentamicin**, both administered as a **solution for injection/infusion**. **Clindamycin** is a chemical-origin antibiotic with a maximum daily dose of 600 mg, administered via **intra-abdominal use**. The treatment period for Clindamycin is limited to one day, with the total dose not exceeding 600 mg. The administration involves a single application of the solution for a duration of three minutes following an appendectomy, as part of a laparoscopic antibiotic peritoneal lavage procedure. Participant compliance is monitored through adherence to the dosing schedule and administration route.

**Gentamicin**, a mixture-origin antibiotic, is also administered as a **solution for injection/infusion** with a maximum daily dose of 240 mg. Similar to Clindamycin, Gentamicin is administered via **intra-abdominal use** for a maximum treatment period of one day, with the total dose not exceeding 240 mg. The administration of Gentamicin follows the same protocol as Clindamycin, involving a single application of the solution for three minutes post-appendectomy. Compliance with the dosing schedule and administration route is monitored to ensure adherence to the study protocol.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are utilized in this study. The focus is solely on evaluating the efficacy of the laparoscopic antibiotic peritoneal lavage with Clindamycin and Gentamicin in reducing the incidence of intra-abdominal abscess in patients with complicated appendicitis.

Efficacy in the clinical trial titled "Laparoscopic Antibiotic Lavage to Prevent intra-abdominal Abscess formation in Complicated Appendicitis (ALPACA)" will be assessed primarily by evaluating the incidence of postoperative intra-abdominal abscess (IAA) within a 30-day follow-up period. This primary endpoint is designed to measure the effectiveness of laparoscopic antibiotic peritoneal lavage using **gentamicin** and **clindamycin** in reducing the occurrence of IAA in patients with complicated appendicitis.

Secondary endpoints will include a range of clinical outcomes measured over a 90-day period. These include wound infections, treatment of IAA, microbial cultures of intra-operative aspirate and postoperative IAA, operating time, readmission rate, reoperation rate, hospital length-of-stay (including readmission), surgical complications according to the Clavien-Dindo classification, mortality, adverse events of antibiotic peritoneal lavage, quality of life, postoperative consultations, and cost-effectivity. These parameters will provide a comprehensive assessment of the treatment's impact on patient health and healthcare resource utilization.