Ongoing Clinical Trials for Complicated Appendicitis
This article provides information about ongoing clinical trials for complicated appendicitis, a severe form of appendicitis where the inflammation has progressed to a more serious stage with potential infection spread. Currently, there is 1 active clinical trial investigating new approaches to prevent complications after surgery for this condition.
Clinical trial locations
Study on Using Gentamicin and Clindamycin to Prevent Abscesses After Surgery for Complicated Appendicitis in Patients
This trial is taking place in the Netherlands and focuses on preventing a serious complication that can occur after surgery for complicated appendicitis. The study investigates whether washing the abdominal area with two antibiotics during surgery can reduce the risk of developing an abscess, which is a collection of pus that can form after the appendix is removed.
Main inclusion criteria: The trial is open to patients aged 8 years or older who have been diagnosed with acute appendicitis before surgery. Participants must be undergoing a laparoscopic appendectomy, which is a minimally invasive surgery using small incisions and a camera to remove the appendix. During the operation, the appendicitis must be confirmed as complicated. Both males and females can participate, and all participants must be able to provide written consent to join the study.
Main exclusion criteria: Patients cannot participate if they have a known allergy to the antibiotics used in the study, specifically gentamicin or clindamycin. Those with a history of severe allergic reactions to any medications are also excluded. Pregnant or breastfeeding women cannot join, as the study treatment might affect the baby. Patients with other serious health conditions that could interfere with the study results, those unable to follow study procedures such as attending appointments, or those already participating in another clinical trial are not eligible.
Focus and goal: The primary goal of this trial is to determine whether using an antibiotic wash during surgery can reduce the risk of developing an intra-abdominal abscess by at least 50%. After the appendix is removed, surgeons will wash the abdominal cavity with a solution containing gentamicin and clindamycin for 3 minutes. Participants will be monitored for 30 days after surgery to check for signs of an abscess, and overall recovery will be observed for up to 90 days. Researchers will also track other aspects such as wound infections, the need for additional treatment, and quality of life during recovery.
Investigational drugs: The trial uses two antibiotics applied directly to the abdominal area during surgery. Gentamicin is an aminoglycoside antibiotic that works by stopping bacteria from making proteins they need to survive, effectively fighting a wide range of bacteria. Clindamycin is a lincosamide antibiotic that also prevents bacterial protein production, stopping bacteria from growing. Together, these antibiotics are intended to reduce the chance of infection and abscess formation after the appendectomy. The study aims to evaluate both the effectiveness and safety of this antibiotic lavage method.
The trial is expected to continue recruiting patients starting in 2025, with the study running until 2027. By participating, patients will contribute to research that could help find better ways to prevent complications for others with complicated appendicitis in the future.
Summary
Currently, there is one active clinical trial for complicated appendicitis, taking place in the Netherlands. This trial focuses specifically on preventing post-surgical complications through the use of antibiotic lavage with gentamicin and clindamycin during laparoscopic appendectomy. The research addresses an important clinical need, as intra-abdominal abscesses can be a serious complication following surgery for this condition. The trial is open to patients aged 8 years and older, making it accessible to both pediatric and adult populations. Recruitment is scheduled to begin in 2025, offering hope for improved surgical outcomes and prevention strategies for those affected by this more severe form of appendicitis.
