NCT02585141

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

4.7 years

First QC Date

October 15, 2015

Last Update Submit

November 10, 2020

Conditions

Anal Fistulas

Outcome Measures

Primary Outcomes (1)

  • Change in recurrence rate

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

    2,12 and 52 weeks

Secondary Outcomes (5)

  • changes in Quality of life score

    2,12 and 52 weeks

  • fecal incontinence

    2,12 and 52 weeks

  • Risk factors for fistula formation and abscess recurrence

    2,12 and 52 weeks

  • Changes in healing time

    2,12 and 52 weeks

  • Changes in fistulas formation

    2,12 and 52 weeks

Study Arms (2)

aspiration

EXPERIMENTAL

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)Drug: Clindamycin

incision

ACTIVE COMPARATOR

Surgical incision of perianal abscess under general anesthesia.

Procedure: incision

Interventions

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.

aspiration
incisionPROCEDURE

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.

incision
ClindamycinDRUG

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

Also known as: postoperative antibiotic
aspiration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (20)

  • 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.

    PMID: 7741334BACKGROUND

  • 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.

    PMID: 9823799BACKGROUND

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

    PMID: 505265BACKGROUND

  • 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.

    PMID: 527452BACKGROUND

  • 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.

    PMID: 6697831BACKGROUND

  • 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.

    PMID: 9247434BACKGROUND

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

    PMID: 6822168BACKGROUND

  • 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;(7):CD006827. doi: 10.1002/14651858.CD006827.pub2.

    PMID: 20614450BACKGROUND

  • 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.

    PMID: 15740520BACKGROUND

  • 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.

    PMID: 3358166BACKGROUND

  • 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.

    PMID: 2327914BACKGROUND

  • 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.

    PMID: 6397949BACKGROUND

  • 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.

    PMID: 3426451BACKGROUND

  • 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.

    PMID: 7720448BACKGROUND

  • 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.

    PMID: 20196412BACKGROUND

  • Devaraj B, Khabassi S, Cosman BC. Recent smoking is a risk factor for anal abscess and fistula. Dis Colon Rectum. 2011 Jun;54(6):681-5. doi: 10.1007/DCR.0b013e31820e7c7a.

    PMID: 21552051BACKGROUND

  • Hamadani A, Haigh PI, Liu IL, Abbas MA. Who is at risk for developing chronic anal fistula or recurrent anal sepsis after initial perianal abscess? Dis Colon Rectum. 2009 Feb;52(2):217-21. doi: 10.1007/DCR.0b013e31819a5c52.

    PMID: 19279415BACKGROUND

  • Smieja M. Current indications for the use of clindamycin: A critical review. Can J Infect Dis. 1998 Jan;9(1):22-8. doi: 10.1155/1998/538090.

    PMID: 22346533BACKGROUND

  • Stevens DL, Bisno AL, Chambers HF, Everett ED, Dellinger P, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan EL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. doi: 10.1086/497143. Epub 2005 Oct 14. No abstract available.

    PMID: 16231249BACKGROUND

  • Sorensen KM, Moller S, Qvist N. Needle aspiration treatment vs. incision of acute simple perianal abscess: randomized controlled study. Int J Colorectal Dis. 2021 Mar;36(3):581-588. doi: 10.1007/s00384-021-03845-6. Epub 2021 Jan 15.

    PMID: 33447866DERIVED

Related Links

MeSH Terms

Conditions

Rectal Fistula

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Karam M Sørensen

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 23, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

DK(1)