NCT01931371

Brief Summary

The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2007

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

6.3 years

First QC Date

August 5, 2013

Last Update Submit

August 22, 2013

Conditions

Anal Fistula

Keywords

fistula in anoanal fistularecurrencecosts

Outcome Measures

Primary Outcomes (1)

  • Anal fistula recurrence rate

    One year

Secondary Outcomes (5)

  • Cost

    3 days

  • Complication rate

    3 days

  • Length of hospital stay

    3 days

  • Independent factors predicting fistula recurrence

    One year

  • Independent factors predicting higher costs

    One year

Study Arms (2)

Recurrent anal fistula

ACTIVE COMPARATOR

Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap

Procedure: Anal Fistula PlugProcedure: Endorectal Advancement Flap

No recurrence of anal fistula

ACTIVE COMPARATOR

Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap

Procedure: Anal Fistula PlugProcedure: Endorectal Advancement Flap

Interventions

Anal Fistula PlugPROCEDURE

Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug

Also known as: Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)
No recurrence of anal fistulaRecurrent anal fistula
Endorectal Advancement FlapPROCEDURE

Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap

Also known as: Advancement Mucosa Flap
No recurrence of anal fistulaRecurrent anal fistula

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18 years of age or more)
  • Single anal fistula
  • Surgically treated with anal fistula plug or endorectal advancement flap

You may not qualify if:

  • Children or adolescents
  • Pregnancy
  • Patients treated with setons alone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery. 2010 Jan;147(1):72-8. doi: 10.1016/j.surg.2009.05.018. Epub 2009 Sep 6.

    PMID: 19733880BACKGROUND

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PMID: 19638912BACKGROUND

MeSH Terms

Conditions

Rectal FistulaRecurrence

Condition Hierarchy (Ancestors)

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

Study Officials

  • Oliver M Fisher, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Antonio Nocito, MD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 29, 2013

Study Start

May 1, 2007

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

CH(1)