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Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

This study is currently recruiting participants.
Verified May 2013 by University Hospital, Akershus
Sponsor:
Collaborators:
Uppsala University Hospital
University Hospital, Linkoeping
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Tom Oresland, Akershus University College
ClinicalTrials.gov Identifier:
NCT01021774
First received: November 27, 2009
Last updated: May 22, 2013
Last verified: May 2013
History of Changes

November 27, 2009
May 22, 2013
November 2009
December 2013   (final data collection date for primary outcome measure)
Anorectal fistula closing rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021774 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery
Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study

The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.

Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Perianal Fistula
Procedure: Anal fistula treatment
A comparison of collagen plug vs advancement flap surgery
Other Names:
  • Perianal
  • Lambeau technique
  • Anal fistula plug
  • Fistula
  • Surgical treatment
  • Active Comparator: Advancement flap surgery
    Intervention: Procedure: Anal fistula treatment
  • Active Comparator: Collagen plug
    Intervention: Procedure: Anal fistula treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with fistula involving > 1/3 of the external anal sphincter
  • Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton)
  • Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug)
  • All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up

Exclusion Criteria:

  • Fistula tract shorter than 2 cm
  • Complex fistula tract system (branching of the fistula tract)
  • Age < 18 years
  • Pregnancy
  • HIV-positivity
  • Fistula caused by malignancy
  • Tuberculosis
  • Hidrosadenitis suppurativa
  • Pilonidal sinus disease
  • No internal fistula opening found
  • Unable/contra indications to go through MRI scanning
  • Crohn´s disease
  • Ulcerative proctitis
Both
18 Years to 85 Years
No
Contact: Tom Oresland, M.D., Ph.D. +47 915 02900 tom.oresland@medisin.uio.no
Contact: Johan Bondi, M.D., Ph.D. +47 915 02900 j.f.d.bondi@medisin.uio.no
Norway
 
NCT01021774
S-08493(REK)
No
Tom Oresland, Akershus University College
University Hospital, Akershus
  • Uppsala University Hospital
  • University Hospital, Linkoeping
  • Sahlgrenska University Hospital, Sweden
Principal Investigator: Tom Oresland, M.D., Ph.D. University Hospital, Akershus
University Hospital, Akershus
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP