NCT01012843

Brief Summary

Purpose: This randomized study assesses the effects of antibiotics on the formation of fistulae after drainage of anorectal abscesses. Methods: Patients who underwent abscess drainage in 3 major colorectal units between September 2005 and January 2008 were included. Previous anorectal surgery history, immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to surgery and the presence of an anal fistulae at the time of surgery were the exclusion criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid combination treatment for 10 days. Patients were followed one year for perianal fistulae formation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

September 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
Last Updated

November 16, 2009

Status Verified

November 1, 2009

Enrollment Period

2.3 years

First QC Date

November 12, 2009

Last Update Submit

November 13, 2009

Conditions

Anal Fistula

Keywords

PerianalAbscessFistulae in anoAntibioticAnorectal

Outcome Measures

Primary Outcomes (1)

  • Fistula formation

    1 year after surgery

Study Arms (2)

Antibiotic

ACTIVE COMPARATOR

Patients who received antibiotic treatment after abscess drainage

Drug: Amoxicillin-Clavulanate

Placebo

PLACEBO COMPARATOR

Patients who received placebo after abscess drainage

Drug: Placebo

Interventions

Amoxicillin-ClavulanateDRUG

oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days

Also known as: Bioment 1 gr BID tablets
Antibiotic
PlaceboDRUG

oral Placebo tablets two times a day for 10 days

Placebo

Eligibility Criteria

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

You may qualify if:

  • Presence of anorectal abscess

You may not qualify if:

  • Allergy to penicillin derivatives
  • Treatment with any antimicrobial agent in the week before enrolment
  • Recognized other infection at the time of surgery
  • Previous anorectal surgery
  • Presence of inflammatory bowel disease
  • Suspicion of Fournier's gangrene
  • Secondary and recurrent anorectal abscesses
  • Presence of an internal opening
  • Any additional surgical procedure performed in the same session or during follow-up
  • Antibiotic prophylaxis indicated for another reason
  • Immunosuppressive and/or anticoagulant drug treatment being taken at the time of surgery
  • Diabetes mellitus
  • Known chronic disabling disease
  • Pregnancy
  • Lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ankara Numune Teaching and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University School of Medicine Department Of General Surgery

Ankara, 06100, Turkey (Türkiye)

Location

Dicle University School of Medicine

Diyarbakır, Turkey (Türkiye)

Location

Related Publications (4)

  • 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

  • Nunoo-Mensah JW, Balasubramaniam S, Wasserberg N, Artinyan A, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr, Vukasin P. Fistula-in-ano: do antibiotics make a difference? Int J Colorectal Dis. 2006 Jul;21(5):441-3. doi: 10.1007/s00384-005-0022-4. Epub 2005 Aug 10.

    PMID: 16091913RESULT

  • 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: 9823799RESULT

  • Ramanujam PS, Prasad ML, Abcarian H, Tan AB. Perianal abscesses and fistulas. A study of 1023 patients. Dis Colon Rectum. 1984 Sep;27(9):593-7. doi: 10.1007/BF02553848.

    PMID: 6468199RESULT

MeSH Terms

Conditions

Rectal FistulaAbscess

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Ulas Sozener, M.D.

    Ankara University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

September 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 16, 2009

Record last verified: 2009-11

Locations

TU(3)