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CompletedNCT01021774Updated Nov 29, 2016

Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

An interventional study of Anal fistula treatment in Perianal Fistula, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by University Hospital, Akershus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Perianal Fistula
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 94 is above the median of 68 across 130 interventional studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
94 participants (actual)

Study arms

  • Active comparator
    Advancement flap surgery

    Procedure: Anal fistula treatment

  • Active comparator
    Collagen plug

    Procedure: Anal fistula treatment

Interventions

  • ProcedureAnal fistula treatment

    A comparison of collagen plug vs advancement flap surgery

    Also known as: Perianal, Lambeau technique, Anal fistula plug, Fistula, Surgical treatment

06

What researchers measure

Primary outcomes

  1. Anorectal fistula closing rate

    Time frame: 1 year

Secondary outcomes

  1. Quality of life

    Time frame: 1 year

07

Study locations

1 site
  • Akershus University Hospital
    Lorenskog, 1478, Norway
08

References and documents

Publications

  • Bondi J, Avdagic J, Karlbom U, Hallbook O, Kalman D, Saltyte Benth J, Naimy N, Oresland T. Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula. Br J Surg. 2017 Aug;104(9):1160-1166. doi: 10.1002/bjs.10549. Epub 2017 May 10. PubMed 28489253 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01021774
Lead sponsor
University Hospital, Akershus
Collaborators
Uppsala University Hospital, University Hospital, Linkoeping, Region Örebro County
Responsible party
Tom Oresland (Professor, University Hospital, Akershus) — Principal investigator
First posted
Nov 30, 2009
Start date
Nov 2009
Primary completion
Jul 2015
Completion
Jun 2016
Last update
Nov 29, 2016

Study contacts

Tom Oresland, M.D., Ph.D.
principal investigator · University Hospital, Akershus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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