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Study on Antibiotic Treatment with Metronidazole and Ciprofloxacin for Patients with Perianal Abscess After Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on the treatment of a condition known as perianal abscess, which is a painful collection of pus near the anus. The study is investigating whether adding antibiotic treatment to the usual surgical procedure for draining the abscess can help reduce the occurrence of a complication called a perianal fistula, which is an abnormal connection that can form between the anal canal and the skin.

The trial involves the use of two antibiotics: Metronidazole and Ciprofloxacin. These are both commonly used medications that help fight bacterial infections. Participants in the study will receive either these antibiotics or a placebo, which looks like the real medication but does not contain any active ingredients. The purpose of the study is to determine if the antibiotics can effectively prevent the development of perianal fistulas after the surgical drainage of the abscess.

Participants in the study will be randomly assigned to receive either the antibiotics or the placebo. The study will be conducted over a period of time, with follow-up assessments to monitor the development of any fistulas and to evaluate other factors such as quality of life, the need for additional procedures, and any complications. The goal is to gather information that could improve treatment outcomes for individuals with perianal abscesses.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must provide written informed consent, confirming understanding of the study's procedures and objectives.
Eligibility criteria include being over 18 years old, having the ability to complete email questionnaires, and understanding Dutch.
Step 2
Surgical drainage procedure
The participant undergoes a surgical procedure to drain the perianal abscess. This is a standard treatment for the condition.
Step 3
Medication administration
Following the surgical procedure, the participant receives medication as part of the trial.
The medications include Metronidazole and Ciprofloxacin, both administered orally in the form of film-coated tablets.
The dosage for each medication is 500 mg. The frequency and duration of administration are determined by the study protocol.
Some participants may receive placebo tablets instead of the active medications.
Step 4
Follow-up and monitoring
Participants are monitored for the development of a perianal fistula within one year, which is the primary endpoint of the study.
Secondary endpoints include assessing quality of life at 12 months, costs, need for repeated drainage, recurrent abscess, complications, patient-reported outcomes, length of hospital stay, readmissions, and time until return to work.
Step 5
Completion of the study
The study is estimated to conclude by July 1, 2026.
Participants will have contributed valuable data to determine the effectiveness of antibiotic treatment in reducing perianal fistulas following surgical drainage.

Who can join the trial?

4 criteria

Must be an adult over 18 years old.
Must be able to receive and respond to email questionnaires.
Must have a good understanding of the Dutch language, both reading and writing.
Must have given written informed consent, which means you agree to participate after being informed about the study.

Who cannot join the trial?

4 criteria

Individuals who do not have a perianal abscess cannot participate. A perianal abscess is a painful, swollen area near the anus filled with pus.
Participants must be within the specified age range, which is not detailed here.
Both males and females are eligible, so gender is not a reason for exclusion.
Vulnerable populations, such as those who might not be able to give informed consent, are not included in this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amphia Hospital
Breda, The Netherlands
Verified
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Diakonessenhuis Stichting
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Antibiotic Treatment is being tested in this trial to see if it can help reduce the occurrence of perianal fistulas after surgical drainage of a perianal abscess. Antibiotics are medications that fight bacterial infections, and in this study, they are used to see if they can improve healing and prevent complications following surgery.

What is already known about the treatment

Amoxicillin – Amoxicillin is an antibiotic administered orally in the form of tablets or liquid suspension. It is widely used in medicine and is well-documented in medical literature. The main therapeutic indication for amoxicillin is the treatment of bacterial infections, including those affecting the skin and soft tissues. At the molecular level, amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It is classified as a penicillin-type antibiotic.

Investigated diseases

Perianal Abscess – A perianal abscess is a painful condition characterized by a collection of pus near the anus. It typically results from an infection of the small anal glands. The abscess may cause swelling, redness, and tenderness in the affected area. As the condition progresses, it can lead to increased pain and discomfort, especially during bowel movements. If not properly managed, a perianal abscess can develop into a perianal fistula, which is an abnormal connection between the anal canal and the skin. The progression of the disease often requires medical intervention to prevent further complications.