Aspiration Treatment of Perianal Abscess

November 10, 2020 updated by: Karam Matlub Sørensen, University of Southern Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aspiration
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)
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.
Drug: Clindamycin
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
Active Comparator: incision
Surgical incision of perianal abscess under general anesthesia.
Procedure: incision
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2,12 and 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2,12 and 52 weeks
fecal incontinence
Time Frame: 2,12 and 52 weeks
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
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.
2,12 and 52 weeks
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.
2,12 and 52 weeks
Changes in fistulas formation
Time Frame: 2,12 and 52 weeks
rate of fistula formation in each arm after 2,12 and 52 weeks
2,12 and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital

Investigators

  • Principal Investigator: Karam M Sørensen, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20140191

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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