Aspiration Treatment of Perianal Abscess

Study Overview
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Brief Summary
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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
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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.

Official Title
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Aspiration or Surgical Drainage of Perianal Abscess. A Randomized Controlled Clinical Study

Conditions
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Anal Fistulas

Intervention / Treatment
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* Device: MEDIPLAST® (aspiration)
* Procedure: incision
* Drug: Clindamycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 yrs old Perianal abscess (without spontaneous rupture) Abscess larger than 2 cm in diameter Signed informed consent Exclusion Criteria: Malignancy within 5 yrs Previous radiotherapy of the abdomen and pelvis Recurrent abscess within 6 months Immune suppressed patients Pregnant and lactating women Abscess with horseshoe formation Allergy to Clindamycin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspiration<br>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 | Device: MEDIPLAST® (aspiration)<br>* The aspiration drainage will be with a large caliber needle (MEDIPLAST® 13 G, 2,5 x 110 mm) and a syringe of 20 ml. The cavity must be emptied for pus and irrigated by repeated injection and aspiration of saline until clear fluid is obtained.<br>Drug: Clindamycin<br>* Postoperative broad spectrum oral antibiotics covering both aerobes and anaerobes bacteria will be given for seven days of Clindamycin 300 mg tablets x 3 a day<br>* Other names: postoperative antibiotic;|
| Active Comparator: incision<br>Surgical incision of perianal abscess under general anesthesia. | Procedure: incision<br>* Incision drainage will be undertaken as standardized de-roofing of the abscess and debridement. Wound packing and dressing will not be used, just sitz bath or ordinary hygiene until wound healing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in recurrence rate | Rate of recurrences of abscesses in each arm after 2,12 and 52 weeks | 2,12 and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Quality of life score | Changes in Short Form Health Survey (SF-36) questionaire after 2,12 and 52 weeks | 2,12 and 52 weeks | 
| fecal incontinence | changes in Wexner fecal incontinence score after 2,12 and 52 weeks | 2,12 and 52 weeks | 
| Risk factors for fistula formation and abscess recurrence | risk factors for recurrences and fistula formation as; age, gender, BMI, smoking and alcohol use. Furthermore presence or absence of the following medical conditions: diabetes mellitus, ischemic cardiac disease, arrhythmia, hypertension, asthma/ COLD, connective tissue disease and renal function impairment. As well as the characteristics of perianal abscess: number of abscesses, localization, distance from anus in cm, largest diameter in cm, length of symptoms and use of antibiotics prior to admission. Finally bacterial culture.Risk factors of developing fistula after both treatments; both medical and abscess related will be analyzed using multivariate analysis. | 2,12 and 52 weeks | 
| Changes in healing time | time to recovery and wound healing after both procedures and it will be measured as the number of days between operation and healed wound. | 2,12 and 52 weeks | 
| Changes in fistulas formation | rate of fistula formation in each arm after 2,12 and 52 weeks | 2,12 and 52 weeks |