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NCT Number: NCT02585141

Aspiration Treatment of Perianal Abscess

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.

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Key information

Conditions

Anal Fistulas Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDIPLAST® (aspiration)

Device

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.

incision

Procedure

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.

Clindamycin

Drug

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

Other names: postoperative antibiotic

Primary outcomes

  1. Change in recurrence rate

    Time frame: 2,12 and 52 weeks

    Rate of recurrences of abscesses in each arm after 2,12 and 52 weeks

Secondary outcomes

  1. changes in Quality of life score

    Time frame: 2,12 and 52 weeks

    Changes in Short Form Health Survey (SF-36) questionaire after 2,12 and 52 weeks

  2. fecal incontinence

    Time frame: 2,12 and 52 weeks

    changes in Wexner fecal incontinence score after 2,12 and 52 weeks

  3. Risk factors for fistula formation and abscess recurrence

    Time frame: 2,12 and 52 weeks

    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.

  4. Changes in healing time

    Time frame: 2,12 and 52 weeks

    time to recovery and wound healing after both procedures and it will be measured as the number of days between operation and healed wound.

  5. Changes in fistulas formation

    Time frame: 2,12 and 52 weeks

    rate of fistula formation in each arm after 2,12 and 52 weeks

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2015
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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