Study on Using Gentamicin and Clindamycin to Prevent Abscesses After Surgery for Complicated Appendicitis in Patients

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What is this study about?

This clinical trial is focused on studying the condition known as appendicitis, specifically a more severe form called complicated appendicitis. The study aims to explore a treatment method involving a procedure called laparoscopic antibiotic lavage. This involves using two antibiotics, clindamycin and gentamicin, to wash the abdominal area after the removal of the appendix. The goal is to see if this method can reduce the risk of developing an intra-abdominal abscess, which is a collection of pus that can occur after surgery.

The purpose of the study is to evaluate whether this antibiotic wash can lower the chances of getting an abscess by at least 50%. Participants in the study will undergo the standard surgical procedure to remove the appendix, known as a laparoscopic appendectomy, and then receive the antibiotic wash. The study will monitor participants for 30 days after the surgery to check for any signs of an abscess. Additionally, other aspects such as wound infections, the need for further treatment, and overall recovery will be observed for up to 90 days.

This trial is designed to gather information on the effectiveness and safety of using antibiotics in this way. By participating, researchers hope to find a better way to prevent complications after surgery for those with complicated appendicitis. The study is expected to continue until 2027, with recruitment starting in 2025.

1 joining the study

Eligibility for participation requires a diagnosis of acute appendicitis, with or without suspicion of complicated appendicitis, and undergoing a laparoscopic appendectomy. Participants must be at least 8 years old and able to provide signed consent.

2 surgical procedure

Undergo a laparoscopic appendectomy. This is a minimally invasive surgery to remove the appendix.

3 antibiotic lavage

After the appendectomy, a laparoscopic antibiotic peritoneal lavage is performed. This involves washing the abdominal cavity with a solution containing gentamicin and clindamycin for 3 minutes. This step aims to reduce the risk of developing an intra-abdominal abscess.

4 postoperative monitoring

Monitor for any signs of postoperative complications, such as intra-abdominal abscess, wound infections, or other surgical complications. This monitoring continues for up to 90 days.

5 follow-up assessments

Attend follow-up appointments to assess recovery and any potential complications. These assessments include checking for wound infections, evaluating the need for further treatment, and monitoring overall health and quality of life.

6 completion of study participation

Participation concludes after the final follow-up assessment, which occurs within 90 days post-surgery. The study aims to evaluate the effectiveness of the antibiotic lavage in reducing the incidence of intra-abdominal abscesses.

Who Can Join the Study?

Patients must be 8 years old or older.
Patients must have a preoperative diagnosis of acute appendicitis. This means the doctor has determined that the appendix is inflamed before surgery.
Patients can have appendicitis with or without signs of it being complicated. Complicated appendicitis means the condition is more severe, possibly with infection spreading.
Patients must be undergoing a laparoscopic appendectomy. This is a type of surgery where small cuts and a camera are used to remove the appendix.
During the surgery, the appendicitis must be confirmed as complicated.
Patients must be able to provide a signed written consent form. This means they agree to participate in the study and understand what it involves.
Both male and female patients can participate.

Who Cannot Join the Study?

Patients who have a known allergy to the antibiotics used in the study, such as gentamicin or clindamycin. These are medications used to fight infections.
Patients who have a history of severe allergic reactions to any medications. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
Patients who are pregnant or breastfeeding. This is because the study might affect the baby.
Patients who have other serious health conditions that might interfere with the study. This means if you have another illness that could make it hard to see how the study treatment is working.
Patients who are unable to follow the study procedures. This means if you can’t do what the study asks, like taking medications or attending appointments.
Patients who are participating in another clinical trial. This is to make sure the results of this study are clear and not mixed with other treatments.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Rode Kruis Ziekenhuis B.V.	Beverwijk	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Zaans Medisch Centrum Stichting	Zaandam	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Dijklander Ziekenhuis	Hoorn	The Netherlands
Ikvvyukvgd Zonozpufbn	Capelle Aan Den Ijssel	The Netherlands
Akisvhame Uhc	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Gentamicin is an antibiotic used in this study to help prevent infections. It is applied directly to the abdominal area during surgery to reduce the risk of developing an abscess after the removal of an inflamed appendix.

Clindamycin is another antibiotic used alongside gentamicin in this trial. It is also applied directly to the abdominal area during surgery. The combination of clindamycin and gentamicin is intended to further decrease the chance of infection and abscess formation after appendectomy.

Investigated diseases:

Appendicitis – Appendicitis is an inflammation of the appendix, a small tube attached to the large intestine. It typically begins with pain near the belly button, which then moves to the lower right side of the abdomen. As the inflammation progresses, the pain becomes sharper and more severe. Other symptoms may include nausea, vomiting, and fever. If not treated, the appendix can burst, leading to more serious complications. The condition is most common in people between the ages of 10 and 30.

Trial ID:

2024-514850-59-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Using Gentamicin and Clindamycin to Prevent Abscesses After Surgery for Complicated Appendicitis in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?