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
1 other identifier
interventional
94
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
1 active site
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
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 27, 2009
CompletedFirst Posted
Study publicly available on registry
November 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 29, 2016
November 1, 2016
5.7 years
November 27, 2009
November 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Anorectal fistula closing rate
1 year
Secondary Outcomes (1)
Quality of life
1 year
Study Arms (2)
Advancement flap surgery
ACTIVE COMPARATORCollagen plug
ACTIVE COMPARATORInterventions
A comparison of collagen plug vs advancement flap surgery
Eligibility Criteria
You may qualify if:
- Patients with fistula involving \> 1/3 of the external anal sphincter
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Akershuslead
- Uppsala University Hospitalcollaborator
- University Hospital, Linkoepingcollaborator
- Region Örebro Countycollaborator
Study Sites (1)
Akershus University Hospital
Lorenskog, 1478, Norway
Related Publications (1)
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.
PMID: 28489253DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Oresland, M.D., Ph.D.
University Hospital, Akershus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 27, 2009
First Posted
November 30, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2015
Study Completion
June 1, 2016
Last Updated
November 29, 2016
Record last verified: 2016-11