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Anal Fistula Plug Versus Endorectal Advancement Flap

NCT ID: NCT01931371

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.

Conditions

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Anal Fistula

Keywords

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fistula in ano anal fistula recurrence costs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recurrent anal fistula

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

Group Type ACTIVE_COMPARATOR

Anal Fistula Plug

Intervention Type PROCEDURE

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

Endorectal Advancement Flap

Intervention Type PROCEDURE

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

No recurrence of anal fistula

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

Group Type ACTIVE_COMPARATOR

Anal Fistula Plug

Intervention Type PROCEDURE

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

Endorectal Advancement Flap

Intervention Type PROCEDURE

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

Interventions

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Anal Fistula Plug

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

Intervention Type PROCEDURE

Endorectal Advancement Flap

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

Intervention Type PROCEDURE

Other Intervention Names

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Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA) Advancement Mucosa Flap

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Children or adolescents
* Pregnancy
* Patients treated with setons alone
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver M Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Antonio Nocito, MD

Role: STUDY_CHAIR

University of Zurich

Locations

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University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 19733880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19638912 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2013-XYZ

Identifier Type: OTHER

Identifier Source: secondary_id

AFPERAF

Identifier Type: -

Identifier Source: org_study_id