AzTrials
AzTrials

Anal FistulasNCT02585141

Aspiration Treatment of Perianal Abscess

A study testing MEDIPLAST® (aspiration), incision and Clindamycin in people with Anal Fistulas, run by University of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Fistulas
What is being tested?
MEDIPLAST® (aspiration), incision and Clindamycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteDenmark
Study dates
Oct 2015to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Conditions
Anal Fistulas
Being tested
MEDIPLAST® (aspiration), incision, Clindamycin
Medical subject headings
Rectal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • incisionProcedure or surgery

    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.

  • ClindamycinDrug

    Also called postoperative antibiotic

    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

Study groups in NCT02585141
Study groupRoleWhat they receive
aspirationExperimentalAspiration 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
Receives: Device: MEDIPLAST® (aspiration); Drug: Clindamycin
incisionActive comparatorSurgical incision of perianal abscess under general anesthesia.
Receives: Procedure: incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in recurrence rate

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

    Measured: 2,12 and 52 weeks

Secondary outcomes (5)

  1. changes in Quality of life score

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

    Measured: 2,12 and 52 weeks

  2. fecal incontinence

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

    Measured: 2,12 and 52 weeks

  3. 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.

    Measured: 2,12 and 52 weeks

  4. 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.

    Measured: 2,12 and 52 weeks

  5. Changes in fistulas formation

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

    Measured: 2,12 and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJun 2020
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585141
Sponsor's protocol ID
S-20140191
Status last verified
Nov 2020
First submitted
15 Oct 2015
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Marcus RH, Stine RJ, Cohen MA. Perirectal abscess. Ann Emerg Med. 1995 May;25(5):597-603. doi: 10.1016/s0196-0644(95)70170-2.

    PubMed 7741334

  • Hamalainen KP, Sainio AP. Incidence of fistulas after drainage of acute anorectal abscesses. Dis Colon Rectum. 1998 Nov;41(11):1357-61; discussion 1361-2. doi: 10.1007/BF02237048.

    PubMed 9823799

  • Kovalcik PJ, Peniston RL, Cross GH. Anorectal abscess. Surg Gynecol Obstet. 1979 Dec;149(6):884-6.

    PubMed 505265

  • Read DR, Abcarian H. A prospective survey of 474 patients with anorectal abscess. Dis Colon Rectum. 1979 Nov-Dec;22(8):566-8. doi: 10.1007/BF02587008.

    PubMed 527452

  • Vasilevsky CA, Gordon PH. The incidence of recurrent abscesses or fistula-in-ano following anorectal suppuration. Dis Colon Rectum. 1984 Feb;27(2):126-30. doi: 10.1007/BF02553995.

    PubMed 6697831

  • Cox SW, Senagore AJ, Luchtefeld MA, Mazier WP. Outcome after incision and drainage with fistulotomy for ischiorectal abscess. Am Surg. 1997 Aug;63(8):686-9.

    PubMed 9247434

  • Chrabot CM, Prasad ML, Abcarian H. Recurrent anorectal abscesses. Dis Colon Rectum. 1983 Feb;26(2):105-8. doi: 10.1007/BF02562586.

    PubMed 6822168

  • Malik AI, Nelson RL, Tou S. Incision and drainage of perianal abscess with or without treatment of anal fistula. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD006827. doi: 10.1002/14651858.CD006827.pub2.

    PubMed 20614450

  • Rickard MJ. Anal abscesses and fistulas. ANZ J Surg. 2005 Jan-Feb;75(1-2):64-72. doi: 10.1111/j.1445-2197.2005.03280.x.

    PubMed 15740520

  • Beck DE, Fazio VW, Lavery IC, Jagelman DG, Weakley FL. Catheter drainage of ischiorectal abscesses. South Med J. 1988 Apr;81(4):444-6. doi: 10.1097/00007611-198804000-00008.

    PubMed 3358166

  • Kyle S, Isbister WH. Management of anorectal abscesses: comparison between traditional incision and packing and de Pezzer catheter drainage. Aust N Z J Surg. 1990 Feb;60(2):129-31.

    PubMed 2327914

  • Kronborg O, Olsen H. Incision and drainage v. incision, curettage and suture under antibiotic cover in anorectal abscess. A randomized study with 3-year follow-up. Acta Chir Scand. 1984;150(8):689-92.

    PubMed 6397949

  • Isbister WH. A simple method for the management of anorectal abscess. Aust N Z J Surg. 1987 Oct;57(10):771-4. doi: 10.1111/j.1445-2197.1987.tb01259.x.

    PubMed 3426451

  • Mortensen J, Kraglund K, Klaerke M, Jaeger G, Svane S, Bone J. Primary suture of anorectal abscess. A randomized study comparing treatment with clindamycin vs. clindamycin and Gentacoll. Dis Colon Rectum. 1995 Apr;38(4):398-401. doi: 10.1007/BF02054229.

    PubMed 7720448

  • Lohsiriwat V, Yodying H, Lohsiriwat D. Incidence and factors influencing the development of fistula-in-ano after incision and drainage of perianal abscesses. J Med Assoc Thai. 2010 Jan;93(1):61-5.

    PubMed 20196412

Questions about this trial

What is this clinical trial studying?

A study testing MEDIPLAST® (aspiration), incision and Clindamycin in people with Anal Fistulas, run by University of Southern Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in recurrence rate (time frame: 2,12 and 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585141, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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