Amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula.

Phase 1

• Conditions: perianal abscess; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2021-003376-14-ES
• Lead Sponsor: Mariano Artes Caselles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-02
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1.Men and women> 18 years
2. First episode of perianal abscess.
3.Tolerance to oral diet.
4. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
5. Signature of the written informed consent in accordance with ICH / GCP and local legislation, obtained before any study procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86

Exclusion Criteria

1. Allergy or intolerance to beta-lactams.
2. Contraindication to the performance of any of the study procedures.
3. History of previous perianal surgery (EABA, episiotomy, etc.).
4. Any clinical condition, and / or analytical alteration that, in the opinion of the investigator, is considered clinically significant to participate in the study. The following are considered as such:
a) Previous or diagnosed perianal fistula during surgery.
b) Complex abscess (horseshoe, supraelevator ...).
c) Marked cellulite after surgical drainage.
d) History of inflammatory bowel disease.
e) History of anal cancer.
f) Previous trauma or radiotherapy.
g) Diabetes mellitus.
h) Immunosuppressed: cancer patients, chronic corticosteroid treatment or other immunosuppressants, chronic kidney disease.
i) Valve prosthesis.
j) Morbid obesity (BMI> 40).
k) Signs of severe sepsis.

5. Women with positive pregnancy test results or breastfeeding.
6. Lack of will or inability to follow the procedures described in the protocol.
7. Inability to give written informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of antibiotic therapy after surgical drainage of the perianal abscess in the development of perianal fistula.;Secondary Objective: -Identify the time elapsed until the appearance of perianal fistula and its complexity according to the St James classification.<br>-Identify relapses in the follow-up and the need for re-surgery surgery<br>-Assess the impact on the quality of life of these patients.<br>-Evaluate safety and tolerability;Primary end point(s): Percentage of patients who develop perianal fistula.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Time elapsed until fistula appearance (months).<br>-Complexity of the fistula according to the St James classification in imaging tests.<br>-Presence of a new episode of perianal abscess in the follow-up.<br>-Need for scheduled surgery for perianal fistula treatment (number of interventions, time elapsed since the initial event and technique used)<br>-Quality of life questionnaire after the appearance of the perianal fistula (QoLAF-Q questionnaire).;Timepoint(s) of evaluation of this end point: Days 30, 90 and 180