Clinical trial NCT02585141: Aspiration Treatment of Perianal Abscess
Official title: Aspiration or Surgical Drainage of Perianal Abscess. A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fistulas
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2015-10-23
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. Included patients will be randomised to either aspiration or incision.

Detailed description: Anorectal abscess is a common condition, caused by cryptoglandular polymicrobial infection, where the traditional treatment is surgical drainage. Anorectal abscess is associated with recurrence rates between 6-44 % after surgical drainage and persistent subsequent fistula up to 37 %. Inadequate incision, missed abscess components or fistulas can be the cause of recurrence . Surgical drainage is associated with discomfort from prolonged wound healing, affecting the daily activities as well as the potential risk of complicated scaring and fecal incontinence. Less invasive method with pus aspiration under antibiotic cover has been shown to be safe in terms of recurrence rate and subsequent fistula formation and well tolerated by the patients with less morbidity and wound complications and a potential lower risk of fecal incontinence. However, this has been shown only in few studies with small population and no randomized controlled study comparing the two approaches has been conducted or published to our knowledge. The risk factors of recurrence and subsequent fistula formation are not that clear but age below 40 years, absence of diabetes mellitus and recent smoking are shown to be risk factors for developing recurrent abscess and fistula. Applying aspiration and antibiotics method for the treatment of perianal abscess can be an advantage for the society due to a shorter recovering period, quicker return to daily activity and work and avoiding wound healing problems and sphincter damage; thus lower expenses. The results of this study have the potentials to reveal the risk factors of developing fistula after perianal abscess.

Eligibility criteria: Inclusion Criteria:

1. ≥18 yrs old
2. Perianal abscess (without spontaneous rupture)
3. Abscess larger than 2 cm in diameter
4. Signed informed consent

Exclusion Criteria:

1. Malignancy within 5 yrs
2. Previous radiotherapy of the abdomen and pelvis
3. Recurrent abscess within 6 months
4. Immune suppressed patients
5. Pregnant and lactating women
6. Abscess with horseshoe formation
7. Allergy to Clindamycin

Primary outcomes:
measure: Change in recurrence rate
timeFrame: 2,12 and 52 weeks
Secondary outcomes:
measure: changes in Quality of life score
timeFrame: 2,12 and 52 weeks
measure: fecal incontinence
timeFrame: 2,12 and 52 weeks
measure: Risk factors for fistula formation and abscess recurrence
timeFrame: 2,12 and 52 weeks
measure: Changes in healing time
timeFrame: 2,12 and 52 weeks
measure: Changes in fistulas formation
timeFrame: 2,12 and 52 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Karam M Sørensen
role: PRINCIPAL_INVESTIGATOR
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