Aspiration Treatment of Perianal Abscess

University of Southern Denmark (SDU)

Status: Completed

Conditions: Anal Fistulas

Treatments: Device: MEDIPLAST® (aspiration); Procedure: incision; Drug: Clindamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02585141

S-20140191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

aspiration

Experimental group

Description:

Aspiration of perianal abscess(MEDIPLAST® 13 G, 2,5 x 110 mm) under general anesthesia followed by antibiotic treatment with Clindamycin tablet 300 mg 3 times daily for 7 days

Treatment:

Drug: Clindamycin

Device: MEDIPLAST® (aspiration)

incision

Active Comparator group

Description:

Surgical incision of perianal abscess under general anesthesia.

Treatment:

Procedure: incision