AuthorisedTherapeutic confirmatory (Phase III)Interventional

The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis (other than for generalized peritonitis): a prospective, randomized, open-label, non-inferiority Phase III study.

This study is investigating the best way to prevent infections after keyhole surgery for a complicated appendix. Researchers want to find out if giving antibiotics after the operation is really necessary, or if it makes a difference to how often patients get new infections. They are comparing different common antibiotics, like metronidazole, ceftriaxone, and levofloxacin, to see which approach works best. The main thing they're looking at is whether patients develop deep surgical site infections in the first 30 days after their surgery. This research will help doctors understand the most effective ways to treat complicated appendicitis and improve patient recovery after surgery.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

1,494

Start

20 Nov 2024

complicated acute appendicitis

What is this study about?

When people have their appendix removed, especially if it's considered 'complicated' (meaning it might have burst or caused other problems), doctors often give antibiotics afterwards. This study wants to find out if this is always the best approach. They are comparing different types of antibiotics sometimes given after surgery to see if they really help prevent infections.

The main goal is to see how many patients get a 'deep surgical site infection' within 30 days of their operation. A deep surgical site infection is one that happens deep inside the body, where the surgery took place, rather than just on the skin. Researchers will be carefully checking for any signs of these infections after the surgery.

This study is important because it will help doctors understand if giving antibiotics after certain appendix operations is truly needed, or if other approaches are just as effective. Better understanding this could help patients recover more quickly, reduce antibiotic use, and potentially lead to better recovery for everyone who has this type of surgery.

Key takeaways

The study aims to improve care for people having appendix surgery.
It's comparing different antibiotics given after keyhole surgery for a complicated appendix.
The main focus is preventing deep infections after surgery.
Adults aged 18 and over are eligible to participate.
Your health will be closely monitored if you take part.

Who may be eligible?

This study is looking for adults aged 18 and over. Both men and women can take part.

You might be able to join if you are having keyhole surgery for acute appendicitis that is considered 'complicated'. This means your appendix might have burst, or there are other complexities, but it does not include very severe cases where there's infection spread throughout the body (called generalized peritonitis).

The doctors will check other specific health details to make sure this study is right for you and safe for you to participate in.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having keyhole surgery for a complicated appendix?
Are you able to provide consent to participate?
Do you understand that this study does not include patients with widespread abdominal infection (generalized peritonitis)?

Answer every question to see your result.

What does participation involve?

If you join this study, your doctors will decide which antibiotics you receive after your appendix surgery. These will be common antibiotics already used by doctors. After your operation, the study team will monitor you closely for 30 days. They will check for any signs of infection, especially deep inside where the surgery happened. They will also ask you to fill out a questionnaire about your quality of life both before your surgery and when you're ready to go home. The duration of your hospital stay will also be noted, as will any need for readmission within the study period.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to new medical knowledge that could help future patients with similar conditions. You will also receive careful monitoring for infections after your surgery. There are no additional risks beyond those normally associated with your appendix surgery and the standard antibiotics used. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'complicated acute appendicitis'?

This means your appendix is inflamed and might have burst or caused other issues, but not a widespread, severe infection in your abdomen.

What does 'keyhole surgery' mean?

It's a type of surgery where doctors make a few small cuts instead of one large one, using special instruments and a camera.

What is a 'deep surgical site infection'?

It's an infection that happens deep inside your body, around the area where you had your operation, usually within 30 days after surgery.

Will I know which antibiotics I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know which antibiotics you are receiving.

Could this study change my recovery?

The goal is to find the best way to prevent infections, which could potentially improve recovery for patients after this type of surgery. Your care will be closely monitored throughout.