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Oral Antibiotics for Anal Abscess (OFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03643198
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : August 12, 2020
Information provided by (Responsible Party):
David Parés MD, PhD, Germans Trias i Pujol Hospital

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.

Condition or disease Intervention/treatment Phase

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arms
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Antibiotics for Anal Abscess to Diminish the Developement of Perianal Fistula
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sham Comparator: CONTROL
The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
NO treatment

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

NO treatment

Primary Outcome Measures :
  1. Perianal fistula incidence [ Time Frame: 12 months ]
    Formation of perianal/anal fistula at follow-up during 12 months after anal abscess. This outcome will be defined clinically and with anal ultrasound.

Secondary Outcome Measures :
  1. Improving on Quality of life [ Time Frame: 12 months ]
    Measurement of quality of life. We will use the test named SF36 in its Validated version in Spanish. This test evaluates the health-related quality of life with answers of 36 questions and punctuates from 0 to 100, being 100 the maximum score (Better quality of life).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
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Responsible Party: David Parés MD, PhD, David parés. MD, PhD. Consultant Surgeon. Associate professor, Germans Trias i Pujol Hospital Identifier: NCT03643198    
Other Study ID Numbers: 2018-001-bcn.nord
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rectal Fistula
Pathological Conditions, Anatomical
Pathologic Processes
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors