Oral Antibiotics for Anal Abscess

NCT03643198 | Unknown

• 1 other identifier: 2018-001-bcn.nord
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND Anal abscess and perianal fistula is a high prevalence disorder in general population that affect adult patients on young ages, affecting them significantly their social and quality of life. There is clinical evidence that the origin of most perianal fistulas (60%) is with an episode one year before of a perianal abscess. In fact, the established cryptoglandular hypothesis considered the origin of anal fistula, a chronic infectious disease starting on a clinical episode of an anal glands abscess. However, controversy exists regarding the role of antibiotics in the development of anal fistula after incision and drainage of perianal abscess. Nowadays, only two single-centre randomized controlled trials has been published addressing this issue, with inconclusive results. The MAIN OBJECTIVE of the study is to examine the clinical benefit of antibiotic therapy in patients with a perianal abscess, to avoid the development of a perianal fistula. METHODOLOGY We designed a prospective, multicentre double-blind placebo trial to analyse the clinical benefit of a course of antibiotics after perianal abscess drainage to diminish the probability of development of perianal fistula in the follow up of patients. Patients with anal abscess will be allocated randomly either to receive 7 days of oral metronidazole/ciprofloxacin in addition to their standard care or to receive standard care and placebo, after they will be discharged from the hospital. Patients will be followed clinically at different intervals during one year in order to know if they develop anal fistula. Also a quality of life assessment at the end of the study will be evaluated. EXPECTED RESULTS We expected that patients allocated to antibiotic treatment would develop a significant less anal fistulas in their follow-up with a related significant better quality of life. Thus, a change on standard of care led by our group, may be achieved.

Conditions

Anal Fistula; Anal Abscess

Outcome Measures

Primary Outcomes (1)

• Perianal fistula incidence

  Formation of perianal/anal fistula at follow-up during 12 months after anal abscess. This outcome will be defined clinically and with anal ultrasound.

  12 months

Secondary Outcomes (1)

• Improving on Quality of life

  12 months

Study Arms (2)

CONTROL

SHAM COMPARATOR

The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.

Other: CONTROL

TREATMENT

ACTIVE COMPARATOR

In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days.

Drug: ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN); Other: CONTROL

Interventions

ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN) DRUG

The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.

TREATMENT

CONTROL OTHER

NO treatment

CONTROL; TREATMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years old
• Clinical diagnosis of perianal abscess

You may not qualify if:

• Participants who have a history of previous perianal abscesses.
• Inflammatory bowel disease
• Patients who already have a perianal fistula
• Patients with perianal cancer and / or pelvic radiotherapy
• Perianal trauma
• Immunodeficiency
• Diabetes
• Pregnancy or lactation
• Valvular heart disease or prosthetic valve carriers
• Spontaneous drainage
• Previous use of antibiotics
• Patients with a known allergy to Ciprofloxacin or Metronidazole.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

David Parés

Barcelona, 08018, Spain

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Interventions

Anti-Bacterial Agents; Metronidazole; Ciprofloxacin

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David parés. MD, PhD. Consultant Surgeon. Associate professor

Model Details: 2 arms

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: August 22, 2018
• Study Start: March 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: December 31, 2025
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

ES (1)