Antibiotic treatment following surgical drainage of perianal abscess: a double-blind, placebo-controlled, randomized trial
This research study is investigating whether taking antibiotics after having surgery for a perianal abscess can help prevent a perianal fistula from developing later. A perianal abscess is a painful collection of pus near the back passage, and a fistula is a small tunnel that can form from where the abscess was to the skin surface. Participants in the study will be given either a commonly used antibiotic, a different antibiotic, or a placebo (a pill with no medicine in it). This is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving, which helps make the results fair. The main aim is to see how many people develop a fistula within one year of their surgery, comparing those who took antibiotics with those who took the placebo. The study is open to adults who have had surgery for a perianal abscess.
At a glance
What is this study about?
When you have a perianal abscess – a painful collection of pus near your bottom – it often needs surgery to drain it. After this surgery, sometimes a complication called a perianal fistula can develop. A fistula is like a small tunnel that connects the inside of your bottom to the skin around it, which can be uncomfortable and might need more treatment.
This study is trying to find out if giving antibiotics after the initial surgery for a perianal abscess can help stop these fistulas from forming. The researchers want to compare different antibiotics with a placebo, which looks just like the real medicine but contains no active drug. This comparison helps them understand if the antibiotics are truly making a difference or if people would get better anyway.
By taking part, you would be helping doctors understand the best way to treat people after perianal abscess surgery. The information gathered from this study could improve future care for many patients. The main thing they will be looking at is whether you develop a fistula within a year of your surgery. They will also look at how this treatment might affect your quality of life, any complications, how long you stay in hospital, and how quickly you can get back to your usual activities.
Key takeaways
- The study investigates if antibiotics prevent fistulas after perianal abscess surgery.
- Participants receive one of two antibiotics or a placebo.
- The main focus is whether a perianal fistula develops within one year.
- Your quality of life and recovery are also being assessed.
- Participation lasts for about one year after surgery.
Who may be eligible?
This study is looking for adults who have recently had surgery to drain a perianal abscess. You will need to be at least 18 years old to take part.
Both men and women are welcome to participate in this study. The researchers want to include a wide range of patients to make sure the results apply to many people.
If you have any questions about whether you might be eligible, it's best to speak with your doctor or the study team.
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?
- Have you recently had surgery to drain a perianal abscess?
- Are you able to attend follow-up appointments for approximately one year?
- Are you willing to potentially receive a placebo (dummy pill)?
What does participation involve?
If you decide to join this study, you will be given one of three treatments: a common antibiotic (Metronidazole), another antibiotic (Ciprofloxacin), or a dummy pill (placebo). You won't know which one you're getting, and neither will your doctor, to keep the study fair. You'll take these pills as instructed by the study team.
After your surgery and starting the study medication, you will have regular check-ups with the study team. These visits will involve questions about how you're feeling and any symptoms you might have. The main goal is to see if a perianal fistula develops within one year. There will also be questions about your quality of life, any other problems, and how quickly you recover.
The total duration of your participation in the study will be about one year. During this time, the team will monitor your progress and gather all the necessary information.
Potential risks and benefits
Locations (1)
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Common questions
What is a perianal abscess?
It's a painful collection of pus that forms near your back passage, usually due to an infection.
What is a perianal fistula?
It's a small tunnel that can form from where an abscess was to the skin surface, often needing more treatment.
What does 'double-blind' mean?
It means neither you nor your doctor will know if you're getting the active antibiotic or the dummy pill (placebo).
What is a placebo?
A placebo is a pill that looks like the study medication but doesn't contain any active drug. It helps compare the real treatment fairly.
How long will I be in the study?
You'll be part of the study for about one year after your surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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